Systems, methods, and workflows for concomitant procedures

ABSTRACT

Systems, methods, and workflows for concomitant procedures are disclosed. In one aspect, the method includes manipulating a flexible instrument using a first robotic arm of a robotic system, manipulating a rigid instrument using a second robotic arm of the robotic system, displaying feedback from the flexible instrument, and displaying feedback from the rigid instrument.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims the benefit of U.S. Provisional Application No.62/831,064, filed Apr. 8, 2019, which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

The systems and methods disclosed herein are directed to systems andmethods for performing medical procedures, and more particularly toconcomitant procedures.

BACKGROUND

Various medical procedures may be performed using a robotic medicalsystem to control the insertion and/or manipulation of one or moremedical instruments. For certain medical conditions, two or more medicalprocedures may be performed to fully treat the medical condition. Therobotic medical system may include one or more robotic arms or any otherinstrument positioning device(s). The robotic medical system may alsoinclude a controller used to control the positioning of theinstrument(s) during each of the procedures via the manipulation of therobotic arm(s) and/or instrument positioning device(s).

SUMMARY

The systems, methods and devices of this disclosure each have severalinnovative aspects, no single one of which is solely responsible for thedesirable attributes disclosed herein.

In one aspect, there is provided a surgical method, comprising:manipulating a flexible instrument using a first robotic arm of arobotic system; manipulating a rigid instrument using a second roboticarm of the robotic system; displaying feedback from the flexibleinstrument; and displaying feedback from the rigid instrument.

In another aspect, there is provided a surgical method, comprising:manipulating a flexible instrument using a first robotic arm of arobotic system; manipulating a rigid instrument using a second roboticarm of the robotic system; displaying first feedback from the flexibleinstrument as a primary view on a viewing screen; and displaying secondfeedback from the rigid instrument as a secondary view on the sameviewing screen.

In yet another aspect, there is provided a surgical method, comprising:manipulating a flexible instrument using a first robotic arm of arobotic system through a natural orifice of a patient; manipulating arigid instrument using a second robotic arm of the robotic systemthrough an incision formed in the patient; and displaying feedbackinformation from the flexible instrument and the rigid instrument.

In still yet another aspect, there is provided a surgical method,comprising: introducing a flexible instrument into a patient via anatural orifice of the patient; and manipulating the flexible instrumentusing a first robotic arm of a robotic system through the naturalorifice; in response to receiving an input signal via a user inputdevice, deploying a second robotic arm of the robotic system from astored position to a set-up position; manipulating a rigid instrumentusing the second robotic arm of the robotic system through an incisionformed in the patient; and displaying feedback from at least one of theflexible instrument and the rigid instrument.

In yet another aspect, there is provided a robotic system, comprising: aflexible instrument; a rigid instrument; a first robotic arm configuredto manipulate the flexible instrument; a second robotic arm configuredto manipulate the rigid instrument; and a display configured to displayvision data from the flexible instrument and the rigid instrument.

In still yet another aspect, there is provided a non-transitory computerreadable storage medium having stored thereon instructions that, whenexecuted, cause at least one computing device to: manipulate a flexibleinstrument using a first robotic arm of a robotic system; manipulate arigid instrument using a second robotic arm of the robotic system;display feedback from the flexible instrument; and display feedback fromthe rigid instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed aspects will hereinafter be described in conjunction withthe appended drawings, provided to illustrate and not to limit thedisclosed aspects, wherein like designations denote like elements.

FIG. 1 illustrates an embodiment of a cart-based robotic system arrangedfor diagnostic and/or therapeutic bronchoscopy procedure(s).

FIG. 2 depicts further aspects of the robotic system of FIG. 1.

FIG. 3 illustrates an embodiment of the robotic system of FIG. 1arranged for ureteroscopy.

FIG. 4 illustrates an embodiment of the robotic system of FIG. 1arranged for a vascular procedure.

FIG. 5 illustrates an embodiment of a table-based robotic systemarranged for a bronchoscopy procedure.

FIG. 6 provides an alternative view of the robotic system of FIG. 5.

FIG. 7 illustrates an example system configured to stow robotic arm(s).

FIG. 8 illustrates an embodiment of a table-based robotic systemconfigured for a ureteroscopy procedure.

FIG. 9 illustrates an embodiment of a table-based robotic systemconfigured for a laparoscopic procedure.

FIG. 10 illustrates an embodiment of the table-based robotic system ofFIGS. 5-9 with pitch or tilt adjustment.

FIG. 11 provides a detailed illustration of the interface between thetable and the column of the table-based robotic system of FIGS. 5-10.

FIG. 12 illustrates an alternative embodiment of a table-based roboticsystem.

FIG. 13 illustrates an end view of the table-based robotic system ofFIG. 12.

FIG. 14 illustrates an end view of a table-based robotic system withrobotic arms attached thereto.

FIG. 15 illustrates an exemplary instrument driver.

FIG. 16 illustrates an exemplary medical instrument with a pairedinstrument driver.

FIG. 17 illustrates an alternative design for an instrument driver andinstrument where the axes of the drive units are parallel to the axis ofthe elongated shaft of the instrument.

FIG. 18 illustrates an instrument having an instrument-based insertionarchitecture.

FIG. 19 illustrates an exemplary controller.

FIG. 20 depicts a block diagram illustrating a localization system thatestimates a location of one or more elements of the robotic systems ofFIGS. 1-10, such as the location of the instrument of FIGS. 16-18, inaccordance to an example embodiment.

FIG. 21 illustrates an embodiment of a bed-based robotic systemconfigured for performing concomitant procedures in accordance withaspects of this disclosure.

FIG. 22 illustrates another embodiment of a bed-based robotic systemconfigured for performing concomitant procedures in accordance withaspects of this disclosure.

FIG. 23 illustrates yet another embodiment of a robotic systemconfigured for performing concomitant procedures in accordance withaspects of this disclosure.

FIGS. 24 and 25 illustrate two configurations of another embodiment of abed-based robotic system configured for performing concomitantprocedures in accordance with aspects of this disclosure.

FIG. 26 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for performing concomitantmedical procedures in accordance with aspects of this disclosure.

FIGS. 27A and 27B provide a flowchart illustrating another examplemethod operable by a robotic system, or component(s) thereof, forperforming concomitant endoscopic and thoracoscopic procedures inaccordance with aspects of this disclosure.

FIG. 28 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for performing concomitantmedical procedures including procedure escalation in accordance withaspects of this disclosure.

FIG. 29 illustrates an example console including one or more types ofinterfaces for controlling robotic arms in accordance with aspects ofthis disclosure.

FIG. 30 illustrates a close-up view of the controller illustrated inFIG. 29 in accordance with aspects of this disclosure.

FIG. 31 illustrates a close-up view one of the handles illustrated inFIGS. 29 and 30 in accordance with aspects of this disclosure.

FIG. 32 illustrates a close-up view of the pendant illustrated in FIG.29 in accordance with aspects of this disclosure.

FIG. 33 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for performing concomitantmedical procedures via a single user interface in accordance withaspects of this disclosure.

FIGS. 34 and 35 are example views which may be displayed by a viewerduring concomitant medical procedures in accordance with aspects of thisdisclosure.

FIG. 36 is another example view which may be displayed by a viewerduring concomitant medical procedures in accordance with aspects of thisdisclosure.

FIG. 37 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for toggling between displayedimages while performing concomitant medical procedures in accordancewith aspects of this disclosure.

FIGS. 38A and 38B are flowcharts illustrating an example workflow forperforming Combined Endoscopic and Laparoscopic Surgery (CELS) inaccordance with aspects of this disclosure.

FIG. 39 illustrates an embodiment of a bed-based robotic systemconfigured for performing a concomitant procedure in accordance withaspects of this disclosure.

FIG. 40 is a flowchart illustrating another example workflow forperforming CELS in accordance with aspects of this disclosure.

FIG. 41 illustrates another embodiment of a robotic system configuredfor performing a concomitant procedure in accordance with aspects ofthis disclosure.

FIG. 42 is an exemplary still image taken from a video screen of theconcomitant system during a colorectal intervention in accordance withaspects of this disclosure.

FIG. 43 is a flowchart illustrating an example patient preparationprocedure for performing CELS in accordance with aspects of thisdisclosure.

FIG. 44 is a flowchart illustrating an example insufflation procedurefor performing CELS in accordance with aspects of this disclosure.

FIG. 45 is a flowchart illustrating an example imaging procedure forperforming CELS in accordance with aspects of this disclosure.

DETAILED DESCRIPTION 1. Overview

Aspects of the present disclosure may be integrated into arobotically-enabled medical system capable of performing a variety ofmedical procedures, including both minimally invasive, such aslaparoscopy, and non-invasive, such as endoscopy, procedures. Amongendoscopy procedures, the system may be capable of performingbronchoscopy, ureteroscopy, gastroscopy, etc.

In addition to performing the breadth of procedures, the system mayprovide additional benefits, such as enhanced imaging and guidance toassist the physician. Additionally, the system may provide the physicianwith the ability to perform the procedure from an ergonomic positionwithout the need for awkward arm motions and positions. Still further,the system may provide the physician with the ability to perform theprocedure with improved ease of use such that one or more of theinstruments of the system can be controlled by a single user.

Various embodiments will be described below in conjunction with thedrawings for purposes of illustration. It should be appreciated thatmany other implementations of the disclosed concepts are possible, andvarious advantages can be achieved with the disclosed implementations.Headings are included herein for reference and to aid in locatingvarious sections. These headings are not intended to limit the scope ofthe concepts described with respect thereto. Such concepts may haveapplicability throughout the entire specification.

A. Robotic System—Cart.

The robotically-enabled medical system may be configured in a variety ofways depending on the particular procedure. FIG. 1 illustrates anembodiment of a cart-based robotically-enabled system 10 arranged for adiagnostic and/or therapeutic bronchoscopy procedure. During abronchoscopy, the system 10 may comprise a cart 11 having one or morerobotic arms 12 to deliver a medical instrument, such as a steerableendoscope 13, which may be a procedure-specific bronchoscope forbronchoscopy, to a natural orifice access point (i.e., the mouth of thepatient positioned on a table in the present example) to deliverdiagnostic and/or therapeutic tools. As shown, the cart 11 may bepositioned proximate to the patient's upper torso in order to provideaccess to the access point. Similarly, the robotic arms 12 may beactuated to position the bronchoscope relative to the access point. Thearrangement in FIG. 1 may also be utilized when performing agastro-intestinal (GI) procedure with a gastroscope, a specializedendoscope for GI procedures. FIG. 2 depicts an example embodiment of thecart in greater detail.

With continued reference to FIG. 1, once the cart 11 is properlypositioned, the robotic arms 12 may insert the steerable endoscope 13into the patient robotically, manually, or a combination thereof. Asshown, the steerable endoscope 13 may comprise at least two telescopingparts, such as an inner leader portion and an outer sheath portion, eachportion coupled to a separate instrument driver (also referred to as aninstrument drive mechanism (IDM)) from the set of instrument drivers 28,each instrument driver coupled to the distal end of an individualrobotic arm. This linear arrangement of the instrument drivers 28, whichfacilitates coaxially aligning the leader portion with the sheathportion, creates a “virtual rail” 29 that may be repositioned in spaceby manipulating the one or more robotic arms 12 into different anglesand/or positions. The virtual rails described herein are depicted in theFigures using dashed lines, and accordingly the dashed lines do notdepict any physical structure of the system. Translation of theinstrument drivers 28 along the virtual rail 29 telescopes the innerleader portion relative to the outer sheath portion or advances orretracts the endoscope 13 from the patient. The angle of the virtualrail 29 may be adjusted, translated, and pivoted based on clinicalapplication or physician preference. For example, in bronchoscopy, theangle and position of the virtual rail 29 as shown represents acompromise between providing physician access to the endoscope 13 whileminimizing friction that results from bending the endoscope 13 into thepatient's mouth.

The endoscope 13 may be directed down the patient's trachea and lungsafter insertion using precise commands from the robotic system untilreaching the target destination or operative site. In order to enhancenavigation through the patient's lung network and/or reach the desiredtarget, the endoscope 13 may be manipulated to telescopically extend theinner leader portion from the outer sheath portion to obtain enhancedarticulation and greater bend radius. The use of separate instrumentdrivers 28 also allows the leader portion and sheath portion to bedriven independent of each other.

For example, the endoscope 13 may be directed to deliver a biopsy needleto a target, such as, for example, a lesion or nodule within the lungsof a patient. The needle may be deployed down a working channel thatruns the length of the endoscope to obtain a tissue sample to beanalyzed by a pathologist. Depending on the pathology results,additional tools may be deployed down the working channel of theendoscope for additional biopsies. After identifying a nodule to bemalignant, the endoscope 13 may endoscopically deliver tools to resectthe potentially cancerous tissue. In some instances, diagnostic andtherapeutic treatments can be delivered in separate procedures. In thosecircumstances, the endoscope 13 may also be used to deliver a fiducialto “mark” the location of the target nodule as well. In other instances,diagnostic and therapeutic treatments may be delivered during the sameprocedure.

The system 10 may also include a movable tower 30, which may beconnected via support cables to the cart 11 to provide support forcontrols, electronics, fluidics, optics, sensors, and/or power to thecart 11. Placing such functionality in the tower 30 allows for a smallerform factor cart 11 that may be more easily adjusted and/orre-positioned by an operating physician and his/her staff. Additionally,the division of functionality between the cart/table and the supporttower 30 reduces operating room clutter and facilitates improvingclinical workflow. While the cart 11 may be positioned close to thepatient, the tower 30 may be stowed in a remote location to stay out ofthe way during a procedure.

In support of the robotic systems described above, the tower 30 mayinclude component(s) of a computer-based control system that storescomputer program instructions, for example, within a non-transitorycomputer-readable storage medium such as a persistent magnetic storagedrive, solid state drive, etc. The execution of those instructions,whether the execution occurs in the tower 30 or the cart 11, may controlthe entire system or sub-system(s) thereof. For example, when executedby a processor of the computer system, the instructions may cause thecomponents of the robotics system to actuate the relevant carriages andarm mounts, actuate the robotics arms, and control the medicalinstruments. For example, in response to receiving the control signal,the motors in the joints of the robotics arms may position the arms intoa certain posture.

The tower 30 may also include a pump, flow meter, valve control, and/orfluid access in order to provide controlled irrigation and aspirationcapabilities to the system that may be deployed through the endoscope13. These components may also be controlled using the computer system oftower 30. In some embodiments, irrigation and aspiration capabilitiesmay be delivered directly to the endoscope 13 through separate cable(s).

The tower 30 may include a voltage and surge protector designed toprovide filtered and protected electrical power to the cart 11, therebyavoiding placement of a power transformer and other auxiliary powercomponents in the cart 11, resulting in a smaller, more moveable cart11.

The tower 30 may also include support equipment for the sensors deployedthroughout the robotic system 10. For example, the tower 30 may includeopto-electronics equipment for detecting, receiving, and processing datareceived from the optical sensors or cameras throughout the roboticsystem 10. In combination with the control system, such opto-electronicsequipment may be used to generate real-time images for display in anynumber of consoles deployed throughout the system, including in thetower 30. Similarly, the tower 30 may also include an electronicsubsystem for receiving and processing signals received from deployedelectromagnetic (EM) sensors. The tower 30 may also be used to house andposition an EM field generator for detection by EM sensors in or on themedical instrument.

The tower 30 may also include a console 31 in addition to other consolesavailable in the rest of the system, e.g., console mounted on top of thecart. The console 31 may include a user interface and a display screen,such as a touchscreen, for the physician operator. Consoles in system 10are generally designed to provide both robotic controls as well aspre-operative and real-time information of the procedure, such asnavigational and localization information of the endoscope 13. When theconsole 31 is not the only console available to the physician, it may beused by a second operator, such as a nurse, to monitor the health orvitals of the patient and the operation of system, as well as provideprocedure-specific data, such as navigational and localizationinformation. In other embodiments, the console 30 is housed in a bodythat is separate from the tower 30.

The tower 30 may be coupled to the cart 11 and endoscope 13 through oneor more cables or connections (not shown). In some embodiments, thesupport functionality from the tower 30 may be provided through a singlecable to the cart 11, simplifying and de-cluttering the operating room.In other embodiments, specific functionality may be coupled in separatecabling and connections. For example, while power may be providedthrough a single power cable to the cart, the support for controls,optics, fluidics, and/or navigation may be provided through a separatecable.

FIG. 2 provides a detailed illustration of an embodiment of the cartfrom the cart-based robotically-enabled system shown in FIG. 1. The cart11 generally includes an elongated support structure 14 (often referredto as a “column”), a cart base 15, and a console 16 at the top of thecolumn 14. The column 14 may include one or more carriages, such as acarriage 17 (alternatively “arm support”) for supporting the deploymentof one or more robotic arms 12 (three shown in FIG. 2). The carriage 17may include individually configurable arm mounts that rotate along aperpendicular axis to adjust the base of the robotic arms 12 for betterpositioning relative to the patient. The carriage 17 also includes acarriage interface 19 that allows the carriage 17 to verticallytranslate along the column 14.

The carriage interface 19 is connected to the column 14 through slots,such as slot 20, that are positioned on opposite sides of the column 14to guide the vertical translation of the carriage 17. The slot 20contains a vertical translation interface to position and hold thecarriage at various vertical heights relative to the cart base 15.Vertical translation of the carriage 17 allows the cart 11 to adjust thereach of the robotic arms 12 to meet a variety of table heights, patientsizes, and physician preferences. Similarly, the individuallyconfigurable arm mounts on the carriage 17 allow the robotic arm base 21of robotic arms 12 to be angled in a variety of configurations.

In some embodiments, the slot 20 may be supplemented with slot coversthat are flush and parallel to the slot surface to prevent dirt andfluid ingress into the internal chambers of the column 14 and thevertical translation interface as the carriage 17 vertically translates.The slot covers may be deployed through pairs of spring spoolspositioned near the vertical top and bottom of the slot 20. The coversare coiled within the spools until deployed to extend and retract fromtheir coiled state as the carriage 17 vertically translates up and down.The spring-loading of the spools provides force to retract the coverinto a spool when carriage 17 translates towards the spool, while alsomaintaining a tight seal when the carriage 17 translates away from thespool. The covers may be connected to the carriage 17 using, forexample, brackets in the carriage interface 19 to facilitate properextension and retraction of the cover as the carriage 17 translates.

The column 14 may internally comprise mechanisms, such as gears andmotors, that are designed to use a vertically aligned lead screw totranslate the carriage 17 in a mechanized fashion in response to controlsignals generated in response to user inputs, e.g., inputs from theconsole 16.

The robotic arms 12 may generally comprise robotic arm bases 21 and endeffectors 22, separated by a series of linkages 23 that are connected bya series of joints 24, each joint comprising an independent actuator,each actuator comprising an independently controllable motor. Eachindependently controllable joint represents an independent degree offreedom available to the robotic arm. Each of the arms 12 have sevenjoints, and thus provide seven degrees of freedom. A multitude of jointsresult in a multitude of degrees of freedom, allowing for “redundant”degrees of freedom. Redundant degrees of freedom allow the robotic arms12 to position their respective end effectors 22 at a specific position,orientation, and trajectory in space using different linkage positionsand joint angles. This allows for the system to position and direct amedical instrument from a desired point in space while allowing thephysician to move the arm joints into a clinically advantageous positionaway from the patient to create greater access, while avoiding armcollisions.

The cart base 15 balances the weight of the column 14, carriage 17, andarms 12 over the floor. Accordingly, the cart base 15 houses heaviercomponents, such as electronics, motors, power supply, as well ascomponents that either enable movement and/or immobilize the cart. Forexample, the cart base 15 includes rollable wheel-shaped casters 25 thatallow for the cart to easily move around the room prior to a procedure.After reaching the appropriate position, the casters 25 may beimmobilized using wheel locks to hold the cart 11 in place during theprocedure.

Positioned at the vertical end of column 14, the console 16 allows forboth a user interface for receiving user input and a display screen (ora dual-purpose device such as, for example, a touchscreen 26) to providethe physician user with both pre-operative and intra-operative data.Potential pre-operative data on the touchscreen 26 may includepre-operative plans, navigation and mapping data derived frompre-operative computerized tomography (CT) scans, and/or notes frompre-operative patient interviews. Intra-operative data on display mayinclude optical information provided from the tool, sensor andcoordinate information from sensors, as well as vital patientstatistics, such as respiration, heart rate, and/or pulse. The console16 may be positioned and tilted to allow a physician to access theconsole from the side of the column 14 opposite carriage 17. From thisposition, the physician may view the console 16, robotic arms 12, andpatient while operating the console 16 from behind the cart 11. Asshown, the console 16 also includes a handle 27 to assist withmaneuvering and stabilizing cart 11.

FIG. 3 illustrates an embodiment of a robotically-enabled system 10arranged for ureteroscopy. In a ureteroscopic procedure, the cart 11 maybe positioned to deliver a ureteroscope 32, a procedure-specificendoscope designed to traverse a patient's urethra and ureter, to thelower abdominal area of the patient. In a ureteroscopy, it may bedesirable for the ureteroscope 32 to be directly aligned with thepatient's urethra to reduce friction and forces on the sensitive anatomyin the area. As shown, the cart 11 may be aligned at the foot of thetable to allow the robotic arms 12 to position the ureteroscope 32 fordirect linear access to the patient's urethra. From the foot of thetable, the robotic arms 12 may the insert ureteroscope 32 along thevirtual rail 33 directly into the patient's lower abdomen through theurethra.

After insertion into the urethra, using similar control techniques as inbronchoscopy, the ureteroscope 32 may be navigated into the bladder,ureters, and/or kidneys for diagnostic and/or therapeutic applications.For example, the ureteroscope 32 may be directed into the ureter andkidneys to break up kidney stone build up using a laser or ultrasoniclithotripsy device deployed down the working channel of the ureteroscope32. After lithotripsy is complete, the resulting stone fragments may beremoved using baskets deployed down the ureteroscope 32.

FIG. 4 illustrates an embodiment of a robotically-enabled systemsimilarly arranged for a vascular procedure. In a vascular procedure,the system 10 may be configured such that the cart 11 may deliver amedical instrument 34, such as a steerable catheter, to an access pointin the femoral artery in the patient's leg. The femoral artery presentsboth a larger diameter for navigation as well as a relatively lesscircuitous and tortuous path to the patient's heart, which simplifiesnavigation. As in a ureteroscopic procedure, the cart 11 may bepositioned towards the patient's legs and lower abdomen to allow therobotic arms 12 to provide a virtual rail 35 with direct linear accessto the femoral artery access point in the patient's thigh/hip region.After insertion into the artery, the medical instrument 34 may bedirected and inserted by translating the instrument drivers 28.Alternatively, the cart may be positioned around the patient's upperabdomen in order to reach alternative vascular access points, such as,for example, the carotid and brachial arteries near the shoulder andwrist.

B. Robotic System—Table.

Embodiments of the robotically-enabled medical system may alsoincorporate the patient's table. Incorporation of the table reduces theamount of capital equipment within the operating room by removing thecart, which allows greater access to the patient. FIG. 5 illustrates anembodiment of such a robotically-enabled system arranged for abronchoscopy procedure. System 36 includes a support structure or column37 for supporting platform 38 (shown as a “table” or “bed”) over thefloor. Much like in the cart-based systems, the end effectors of therobotic arms 39 of the system 36 comprise instrument drivers 42 that aredesigned to manipulate an elongated medical instrument, such as abronchoscope 40 in FIG. 5, through or along a virtual rail 41 formedfrom the linear alignment of the instrument drivers 42. In practice, aC-arm for providing fluoroscopic imaging may be positioned over thepatient's upper abdominal area by placing the emitter and detectoraround table 38.

FIG. 6 provides an alternative view of the system 36 without the patientand medical instrument for discussion purposes. As shown, the column 37may include one or more carriages 43 shown as ring-shaped in the system36, from which the one or more robotic arms 39 may be based. Thecarriages 43 may translate along a vertical column interface 44 thatruns the length of the column 37 to provide different vantage pointsfrom which the robotic arms 39 may be positioned to reach the patient.The carriage(s) 43 may rotate around the column 37 using a mechanicalmotor positioned within the column 37 to allow the robotic arms 39 tohave access to multiples sides of the table 38, such as, for example,both sides of the patient. In embodiments with multiple carriages, thecarriages may be individually positioned on the column and may translateand/or rotate independent of the other carriages. While carriages 43need not surround the column 37 or even be circular, the ring-shape asshown facilitates rotation of the carriages 43 around the column 37while maintaining structural balance. Rotation and translation of thecarriages 43 allows the system to align the medical instruments, such asendoscopes and laparoscopes, into different access points on thepatient. In other embodiments (not shown), the system 36 can include apatient table or bed with adjustable arm supports in the form of bars orrails extending alongside it. One or more robotic arms 39 (e.g., via ashoulder with an elbow joint) can be attached to the adjustable armsupports, which can be vertically adjusted. By providing verticaladjustment, the robotic arms 39 are advantageously capable of beingstowed compactly beneath the patient table or bed, and subsequentlyraised during a procedure.

The arms 39 may be mounted on the carriages through a set of arm mounts45 comprising a series of joints that may individually rotate and/ortelescopically extend to provide additional configurability to therobotic arms 39. Additionally, the arm mounts 45 may be positioned onthe carriages 43 such that, when the carriages 43 are appropriatelyrotated, the arm mounts 45 may be positioned on either the same side oftable 38 (as shown in FIG. 6), on opposite sides of table 38 (as shownin FIG. 9), or on adjacent sides of the table 38 (not shown).

The column 37 structurally provides support for the table 38, and a pathfor vertical translation of the carriages. Internally, the column 37 maybe equipped with lead screws for guiding vertical translation of thecarriages, and motors to mechanize the translation of said carriagesbased the lead screws. The column 37 may also convey power and controlsignals to the carriage 43 and robotic arms 39 mounted thereon.

The table base 46 serves a similar function as the cart base 15 in cart11 shown in FIG. 2, housing heavier components to balance the table/bed38, the column 37, the carriages 43, and the robotic arms 39. The tablebase 46 may also incorporate rigid casters to provide stability duringprocedures. Deployed from the bottom of the table base 46, the castersmay extend in opposite directions on both sides of the base 46 andretract when the system 36 needs to be moved.

Continuing with FIG. 6, the system 36 may also include a tower (notshown) that divides the functionality of system 36 between table andtower to reduce the form factor and bulk of the table. As in earlierdisclosed embodiments, the tower may provide a variety of supportfunctionalities to table, such as processing, computing, and controlcapabilities, power, fluidics, and/or optical and sensor processing. Thetower may also be movable to be positioned away from the patient toimprove physician access and de-clutter the operating room.Additionally, placing components in the tower allows for more storagespace in the table base for potential stowage of the robotic arms. Thetower may also include a master controller or console that provides botha user interface for user input, such as keyboard and/or pendant, aswell as a display screen (or touchscreen) for pre-operative andintra-operative information, such as real-time imaging, navigation, andtracking information. In some embodiments, the tower may also containholders for gas tanks to be used for insufflation.

In some embodiments, a table base may stow and store the robotic armswhen not in use. FIG. 7 illustrates a system 47 that stows robotic armsin an embodiment of the table-based system. In system 47, carriages 48may be vertically translated into base 49 to stow robotic arms 50, armmounts 51, and the carriages 48 within the base 49. Base covers 52 maybe translated and retracted open to deploy the carriages 48, arm mounts51, and arms 50 around column 53, and closed to stow to protect themwhen not in use. The base covers 52 may be sealed with a membrane 54along the edges of its opening to prevent dirt and fluid ingress whenclosed.

FIG. 8 illustrates an embodiment of a robotically-enabled table-basedsystem configured for a ureteroscopy procedure. In a ureteroscopy, thetable 38 may include a swivel portion 55 for positioning a patientoff-angle from the column 37 and table base 46. The swivel portion 55may rotate or pivot around a pivot point (e.g., located below thepatient's head) in order to position the bottom portion of the swivelportion 55 away from the column 37. For example, the pivoting of theswivel portion 55 allows a C-arm (not shown) to be positioned over thepatient's lower abdomen without competing for space with the column (notshown) below table 38. By rotating the carriage 35 (not shown) aroundthe column 37, the robotic arms 39 may directly insert a ureteroscope 56along a virtual rail 57 into the patient's groin area to reach theurethra. In a ureteroscopy, stirrups 58 may also be fixed to the swivelportion 55 of the table 38 to support the position of the patient's legsduring the procedure and allow clear access to the patient's groin area.

In a laparoscopic procedure, through small incision(s) in the patient'sabdominal wall, minimally invasive instruments may be inserted into thepatient's anatomy. In some embodiments, the minimally invasiveinstruments comprise an elongated rigid member, such as a shaft, whichis used to access anatomy within the patient. After inflation of thepatient's abdominal cavity, the instruments may be directed to performsurgical or medical tasks, such as grasping, cutting, ablating,suturing, etc. In some embodiments, the instruments can comprise ascope, such as a laparoscope. FIG. 9 illustrates an embodiment of arobotically-enabled table-based system configured for a laparoscopicprocedure. As shown in FIG. 9, the carriages 43 of the system 36 may berotated and vertically adjusted to position pairs of the robotic arms 39on opposite sides of the table 38, such that instrument 59 may bepositioned using the arm mounts 45 to be passed through minimalincisions on both sides of the patient to reach his/her abdominalcavity.

To accommodate laparoscopic procedures, the robotically-enabled tablesystem may also tilt the platform to a desired angle. FIG. 10illustrates an embodiment of the robotically-enabled medical system withpitch or tilt adjustment. As shown in FIG. 10, the system 36 mayaccommodate tilt of the table 38 to position one portion of the table ata greater distance from the floor than the other. Additionally, the armmounts 45 may rotate to match the tilt such that the arms 39 maintainthe same planar relationship with table 38. To accommodate steeperangles, the column 37 may also include telescoping portions 60 thatallow vertical extension of column 37 to keep the table 38 from touchingthe floor or colliding with base 46.

FIG. 11 provides a detailed illustration of the interface between thetable 38 and the column 37. Pitch rotation mechanism 61 may beconfigured to alter the pitch angle of the table 38 relative to thecolumn 37 in multiple degrees of freedom. The pitch rotation mechanism61 may be enabled by the positioning of orthogonal axes 1, 2 at thecolumn-table interface, each axis actuated by a separate motor 3, 4responsive to an electrical pitch angle command. Rotation along onescrew 5 would enable tilt adjustments in one axis 1, while rotationalong the other screw 6 would enable tilt adjustments along the otheraxis 2. In some embodiments, a ball joint can be used to alter the pitchangle of the table 38 relative to the column 37 in multiple degrees offreedom.

For example, pitch adjustments are particularly useful when trying toposition the table in a Trendelenburg position, i.e., position thepatient's lower abdomen at a higher position from the floor than thepatient's lower abdomen, for lower abdominal surgery. The Trendelenburgposition causes the patient's internal organs to slide towards his/herupper abdomen through the force of gravity, clearing out the abdominalcavity for minimally invasive tools to enter and perform lower abdominalsurgical or medical procedures, such as laparoscopic prostatectomy.

FIGS. 12 and 13 illustrate isometric and end views of an alternativeembodiment of a table-based surgical robotics system 100. The surgicalrobotics system 100 includes one or more adjustable arm supports 105that can be configured to support one or more robotic arms (see, forexample, FIG. 14) relative to a table 101. In the illustratedembodiment, a single adjustable arm support 105 is shown, though anadditional arm support can be provided on an opposite side of the table101. The adjustable arm support 105 can be configured so that it canmove relative to the table 101 to adjust and/or vary the position of theadjustable arm support 105 and/or any robotic arms mounted theretorelative to the table 101. For example, the adjustable arm support 105may be adjusted one or more degrees of freedom relative to the table101. The adjustable arm support 105 provides high versatility to thesystem 100, including the ability to easily stow the one or moreadjustable arm supports 105 and any robotics arms attached theretobeneath the table 101. The adjustable arm support 105 can be elevatedfrom the stowed position to a position below an upper surface of thetable 101. In other embodiments, the adjustable arm support 105 can beelevated from the stowed position to a position above an upper surfaceof the table 101.

The adjustable arm support 105 can provide several degrees of freedom,including lift (e.g., vertical translation), lateral translation, tilt,etc. In the illustrated embodiment of FIGS. 12 and 13, the arm support105 is configured with four degrees of freedom, which are illustratedwith arrows in FIG. 12. A first degree of freedom allows for adjustmentof the adjustable arm support 105 in the z-direction (“Z-lift”). Forexample, the adjustable arm support 105 can include a carriage 109configured to move up or down along or relative to a column 102supporting the table 101. A second degree of freedom can allow theadjustable arm support 105 to tilt. For example, the adjustable armsupport 105 can include a rotary joint, which can allow the adjustablearm support 105 to be aligned with the bed in a Trendelenburg position.A third degree of freedom can allow the adjustable arm support 105 to“pivot up,” which can be used to adjust a distance between a side of thetable 101 and the adjustable arm support 105. A fourth degree of freedomcan permit translation of the adjustable arm support 105 along alongitudinal length of the table.

The surgical robotics system 100 in FIGS. 12 and 13 can comprise a tablesupported by a column 102 that is mounted to a base 103. The base 103and the column 102 support the table 101 relative to a support surface.A floor axis 131 and a support axis 133 are shown in FIG. 13.

The adjustable arm support 105 can be mounted to the column 102. Inother embodiments, the arm support 105 can be mounted to the table 101or base 103. The adjustable arm support 105 can include a carriage 109,a bar or rail connector 111 and a bar or rail 107. In some embodiments,one or more robotic arms mounted to the rail 107 can translate and moverelative to one another.

The carriage 109 can be attached to the column 102 by a first joint 113,which allows the carriage 109 to move relative to the column 102 (e.g.,such as up and down a first or vertical axis 123). The first joint 113can provide the first degree of freedom (Z-lift) to the adjustable armsupport 105. The adjustable arm support 105 can include a second joint115, which provides the second degree of freedom (tilt) for theadjustable arm support 105. The adjustable arm support 105 can include athird joint 117, which can provide the third degree of freedom (“pivotup”) for the adjustable arm support 105. An additional joint 119 (shownin FIG. 13) can be provided that mechanically constrains the third joint117 to maintain an orientation of the rail 107 as the rail connector 111is rotated about a third axis 127. The adjustable arm support 105 caninclude a fourth joint 121, which can provide a fourth degree of freedom(translation) for the adjustable arm support 105 along a fourth axis129.

FIG. 14 illustrates an end view of the surgical robotics system 140Awith two adjustable arm supports 105A, 105B mounted on opposite sides ofa table 101. A first robotic arm 142A is attached to the bar or rail107A of the first adjustable arm support 105B. The first robotic arm142A includes a base 144A attached to the rail 107A. The distal end ofthe first robotic arm 142A includes an instrument drive mechanism 146Athat can attach to one or more robotic medical instruments or tools.Similarly, the second robotic arm 142B includes a base 144B attached tothe rail 107B. The distal end of the second robotic arm 142B includes aninstrument drive mechanism 146B. The instrument drive mechanism 146B canbe configured to attach to one or more robotic medical instruments ortools.

In some embodiments, one or more of the robotic arms 142A, 142Bcomprises an arm with seven or more degrees of freedom. In someembodiments, one or more of the robotic arms 142A, 142B can includeeight degrees of freedom, including an insertion axis (1-degree offreedom including insertion), a wrist (3-degrees of freedom includingwrist pitch, yaw and roll), an elbow (1-degree of freedom includingelbow pitch), a shoulder (2-degrees of freedom including shoulder pitchand yaw), and base 144A, 144B (1-degree of freedom includingtranslation). In some embodiments, the insertion degree of freedom canbe provided by the robotic arm 142A, 142B, while in other embodiments,the instrument itself provides insertion via an instrument-basedinsertion architecture.

C. Instrument Driver & Interface.

The end effectors of the system's robotic arms comprise (i) aninstrument driver (alternatively referred to as “instrument drivemechanism” or “instrument device manipulator”) that incorporateelectro-mechanical means for actuating the medical instrument and (ii) aremovable or detachable medical instrument, which may be devoid of anyelectro-mechanical components, such as motors. This dichotomy may bedriven by the need to sterilize medical instruments used in medicalprocedures, and the inability to adequately sterilize expensive capitalequipment due to their intricate mechanical assemblies and sensitiveelectronics. Accordingly, the medical instruments may be designed to bedetached, removed, and interchanged from the instrument driver (and thusthe system) for individual sterilization or disposal by the physician orthe physician's staff. In contrast, the instrument drivers need not bechanged or sterilized, and may be draped for protection.

FIG. 15 illustrates an example instrument driver. Positioned at thedistal end of a robotic arm, instrument driver 62 comprises of one ormore drive units 63 arranged with parallel axes to provide controlledtorque to a medical instrument via drive shafts 64. Each drive unit 63comprises an individual drive shaft 64 for interacting with theinstrument, a gear head 65 for converting the motor shaft rotation to adesired torque, a motor 66 for generating the drive torque, an encoder67 to measure the speed of the motor shaft and provide feedback to thecontrol circuitry, and control circuitry 68 for receiving controlsignals and actuating the drive unit. Each drive unit 63 beingindependent controlled and motorized, the instrument driver 62 mayprovide multiple (e.g., four as shown in FIG. 15) independent driveoutputs to the medical instrument. In operation, the control circuitry68 would receive a control signal, transmit a motor signal to the motor66, compare the resulting motor speed as measured by the encoder 67 withthe desired speed, and modulate the motor signal to generate the desiredtorque.

For procedures that require a sterile environment, the robotic systemmay incorporate a drive interface, such as a sterile adapter connectedto a sterile drape, that sits between the instrument driver and themedical instrument. The chief purpose of the sterile adapter is totransfer angular motion from the drive shafts of the instrument driverto the drive inputs of the instrument while maintaining physicalseparation, and thus sterility, between the drive shafts and driveinputs. Accordingly, an example sterile adapter may comprise of a seriesof rotational inputs and outputs intended to be mated with the driveshafts of the instrument driver and drive inputs on the instrument.Connected to the sterile adapter, the sterile drape, comprised of athin, flexible material such as transparent or translucent plastic, isdesigned to cover the capital equipment, such as the instrument driver,robotic arm, and cart (in a cart-based system) or table (in atable-based system). Use of the drape would allow the capital equipmentto be positioned proximate to the patient while still being located inan area not requiring sterilization (i.e., non-sterile field). On theother side of the sterile drape, the medical instrument may interfacewith the patient in an area requiring sterilization (i.e., sterilefield).

D. Medical Instrument.

FIG. 16 illustrates an example medical instrument with a pairedinstrument driver. Like other instruments designed for use with arobotic system, medical instrument 70 comprises an elongated shaft 71(or elongate body) and an instrument base 72. The instrument base 72,also referred to as an “instrument handle” due to its intended designfor manual interaction by the physician, may generally compriserotatable drive inputs 73, e.g., receptacles, pulleys or spools, thatare designed to be mated with drive outputs 74 that extend through adrive interface on instrument driver 75 at the distal end of robotic arm76. When physically connected, latched, and/or coupled, the mated driveinputs 73 of instrument base 72 may share axes of rotation with thedrive outputs 74 in the instrument driver 75 to allow the transfer oftorque from drive outputs 74 to drive inputs 73. In some embodiments,the drive outputs 74 may comprise splines that are designed to mate withreceptacles on the drive inputs 73.

The elongated shaft 71 is designed to be delivered through either ananatomical opening or lumen, e.g., as in endoscopy, or a minimallyinvasive incision, e.g., as in laparoscopy. The elongated shaft 71 maybe either flexible (e.g., having properties similar to an endoscope) orrigid (e.g., having properties similar to a laparoscope) or contain acustomized combination of both flexible and rigid portions. Whendesigned for laparoscopy, the distal end of a rigid elongated shaft maybe connected to an end effector extending from a jointed wrist formedfrom a clevis with at least one degree of freedom and a surgical tool ormedical instrument, such as, for example, a grasper or scissors, thatmay be actuated based on force from the tendons as the drive inputsrotate in response to torque received from the drive outputs 74 of theinstrument driver 75. When designed for endoscopy, the distal end of aflexible elongated shaft may include a steerable or controllable bendingsection that may be articulated and bent based on torque received fromthe drive outputs 74 of the instrument driver 75.

Torque from the instrument driver 75 is transmitted down the elongatedshaft 71 using tendons along the shaft 71. These individual tendons,such as pull wires, may be individually anchored to individual driveinputs 73 within the instrument handle 72. From the handle 72, thetendons are directed down one or more pull lumens along the elongatedshaft 71 and anchored at the distal portion of the elongated shaft 71,or in the wrist at the distal portion of the elongated shaft. During asurgical procedure, such as a laparoscopic, endoscopic or hybridprocedure, these tendons may be coupled to a distally mounted endeffector, such as a wrist, grasper, or scissor. Under such anarrangement, torque exerted on drive inputs 73 would transfer tension tothe tendon, thereby causing the end effector to actuate in some way. Insome embodiments, during a surgical procedure, the tendon may cause ajoint to rotate about an axis, thereby causing the end effector to movein one direction or another. Alternatively, the tendon may be connectedto one or more jaws of a grasper at distal end of the elongated shaft71, where tension from the tendon cause the grasper to close.

In endoscopy, the tendons may be coupled to a bending or articulatingsection positioned along the elongated shaft 71 (e.g., at the distalend) via adhesive, control ring, or other mechanical fixation. Whenfixedly attached to the distal end of a bending section, torque exertedon drive inputs 73 would be transmitted down the tendons, causing thesofter, bending section (sometimes referred to as the articulablesection or region) to bend or articulate. Along the non-bendingsections, it may be advantageous to spiral or helix the individual pulllumens that direct the individual tendons along (or inside) the walls ofthe endoscope shaft to balance the radial forces that result fromtension in the pull wires. The angle of the spiraling and/or spacingthere between may be altered or engineered for specific purposes,wherein tighter spiraling exhibits lesser shaft compression under loadforces, while lower amounts of spiraling results in greater shaftcompression under load forces, but also exhibits limits bending. On theother end of the spectrum, the pull lumens may be directed parallel tothe longitudinal axis of the elongated shaft 71 to allow for controlledarticulation in the desired bending or articulable sections.

In endoscopy, the elongated shaft 71 houses a number of components toassist with the robotic procedure. The shaft may comprise of a workingchannel for deploying surgical tools (or medical instruments),irrigation, and/or aspiration to the operative region at the distal endof the shaft 71. The shaft 71 may also accommodate wires and/or opticalfibers to transfer signals to/from an optical assembly at the distaltip, which may include of an optical camera. The shaft 71 may alsoaccommodate optical fibers to carry light from proximally-located lightsources, such as light emitting diodes, to the distal end of the shaft.

At the distal end of the instrument 70, the distal tip may also comprisethe opening of a working channel for delivering tools for diagnosticand/or therapy, irrigation, and aspiration to an operative site. Thedistal tip may also include a port for a camera, such as a fiberscope ora digital camera, to capture images of an internal anatomical space.Relatedly, the distal tip may also include ports for light sources forilluminating the anatomical space when using the camera.

In the example of FIG. 16, the drive shaft axes, and thus the driveinput axes, are orthogonal to the axis of the elongated shaft. Thisarrangement, however, complicates roll capabilities for the elongatedshaft 71. Rolling the elongated shaft 71 along its axis while keepingthe drive inputs 73 static results in undesirable tangling of thetendons as they extend off the drive inputs 73 and enter pull lumenswithin the elongated shaft 71. The resulting entanglement of suchtendons may disrupt any control algorithms intended to predict movementof the flexible elongated shaft during an endoscopic procedure.

FIG. 17 illustrates an alternative design for an instrument driver andinstrument where the axes of the drive units are parallel to the axis ofthe elongated shaft of the instrument. As shown, a circular instrumentdriver 80 comprises four drive units with their drive outputs 81 alignedin parallel at the end of a robotic arm 82. The drive units, and theirrespective drive outputs 81, are housed in a rotational assembly 83 ofthe instrument driver 80 that is driven by one of the drive units withinthe assembly 83. In response to torque provided by the rotational driveunit, the rotational assembly 83 rotates along a circular bearing thatconnects the rotational assembly 83 to the non-rotational portion 84 ofthe instrument driver. Power and controls signals may be communicatedfrom the non-rotational portion 84 of the instrument driver 80 to therotational assembly 83 through electrical contacts may be maintainedthrough rotation by a brushed slip ring connection (not shown). In otherembodiments, the rotational assembly 83 may be responsive to a separatedrive unit that is integrated into the non-rotatable portion 84, andthus not in parallel to the other drive units. The rotational mechanism83 allows the instrument driver 80 to rotate the drive units, and theirrespective drive outputs 81, as a single unit around an instrumentdriver axis 85.

Like earlier disclosed embodiments, an instrument 86 may comprise anelongated shaft portion 88 and an instrument base 87 (shown with atransparent external skin for discussion purposes) comprising aplurality of drive inputs 89 (such as receptacles, pulleys, and spools)that are configured to receive the drive outputs 81 in the instrumentdriver 80. Unlike prior disclosed embodiments, instrument shaft 88extends from the center of instrument base 87 with an axis substantiallyparallel to the axes of the drive inputs 89, rather than orthogonal asin the design of FIG. 16.

When coupled to the rotational assembly 83 of the instrument driver 80,the medical instrument 86, comprising instrument base 87 and instrumentshaft 88, rotates in combination with the rotational assembly 83 aboutthe instrument driver axis 85. Since the instrument shaft 88 ispositioned at the center of instrument base 87, the instrument shaft 88is coaxial with instrument driver axis 85 when attached. Thus, rotationof the rotational assembly 83 causes the instrument shaft 88 to rotateabout its own longitudinal axis. Moreover, as the instrument base 87rotates with the instrument shaft 88, any tendons connected to the driveinputs 89 in the instrument base 87 are not tangled during rotation.Accordingly, the parallelism of the axes of the drive outputs 81, driveinputs 89, and instrument shaft 88 allows for the shaft rotation withouttangling any control tendons.

FIG. 18 illustrates an instrument having an instrument based insertionarchitecture in accordance with some embodiments. The instrument 150 canbe coupled to any of the instrument drivers discussed above. Theinstrument 150 comprises an elongated shaft 152, an end effector 162connected to the shaft 152, and a handle 170 coupled to the shaft 152.The elongated shaft 152 comprises a tubular member having a proximalportion 154 and a distal portion 156. The elongated shaft 152 comprisesone or more channels or grooves 158 along its outer surface. The grooves158 are configured to receive one or more wires or cables 180therethrough. One or more cables 180 thus run along an outer surface ofthe elongated shaft 152. In other embodiments, cables 180 can also runthrough the elongated shaft 152. Manipulation of the one or more cables180 (e.g., via an instrument driver) results in actuation of the endeffector 162.

The instrument handle 170, which may also be referred to as aninstrument base, may generally comprise an attachment interface 172having one or more mechanical inputs 174, e.g., receptacles, pulleys orspools, that are designed to be reciprocally mated with one or moretorque couplers on an attachment surface of an instrument driver.

In some embodiments, the instrument 150 comprises a series of pulleys orcables that enable the elongated shaft 152 to translate relative to thehandle 170. In other words, the instrument 150 itself comprises aninstrument-based insertion architecture that accommodates insertion ofthe instrument, thereby minimizing the reliance on a robot arm toprovide insertion of the instrument 150. In other embodiments, a roboticarm can be largely responsible for instrument insertion.

E. Controller.

Any of the robotic systems described herein can include an input deviceor controller for manipulating an instrument attached to a robotic arm.In some embodiments, the controller can be coupled (e.g.,communicatively, electronically, electrically, wirelessly and/ormechanically) with an instrument such that manipulation of thecontroller causes a corresponding manipulation of the instrument e.g.,via master slave control.

FIG. 19 is a perspective view of an embodiment of a controller 182. Inthe present embodiment, the controller 182 comprises a hybrid controllerthat can have both impedance and admittance control. In otherembodiments, the controller 182 can utilize just impedance or passivecontrol. In other embodiments, the controller 182 can utilize justadmittance control. By being a hybrid controller, the controller 182advantageously can have a lower perceived inertia while in use.

In the illustrated embodiment, the controller 182 is configured to allowmanipulation of two medical instruments, and includes two handles 184.Each of the handles 184 is connected to a gimbal 186. Each gimbal 186 isconnected to a positioning platform 188.

As shown in FIG. 19, each positioning platform 188 includes a SCARA arm(selective compliance assembly robot arm) 198 coupled to a column 194 bya prismatic joint 196. The prismatic joints 196 are configured totranslate along the column 194 (e.g., along rails 197) to allow each ofthe handles 184 to be translated in the z-direction, providing a firstdegree of freedom. The SCARA arm 198 is configured to allow motion ofthe handle 184 in an x-y plane, providing two additional degrees offreedom.

In some embodiments, one or more load cells are positioned in thecontroller. For example, in some embodiments, a load cell (not shown) ispositioned in the body of each of the gimbals 186. By providing a loadcell, portions of the controller 182 are capable of operating underadmittance control, thereby advantageously reducing the perceivedinertia of the controller while in use. In some embodiments, thepositioning platform 188 is configured for admittance control, while thegimbal 186 is configured for impedance control. In other embodiments,the gimbal 186 is configured for admittance control, while thepositioning platform 188 is configured for impedance control.Accordingly, for some embodiments, the translational or positionaldegrees of freedom of the positioning platform 188 can rely onadmittance control, while the rotational degrees of freedom of thegimbal 186 rely on impedance control.

F. Navigation and Control.

Traditional endoscopy may involve the use of fluoroscopy (e.g., as maybe delivered through a C-arm) and other forms of radiation-based imagingmodalities to provide endoluminal guidance to an operator physician. Incontrast, the robotic systems contemplated by this disclosure canprovide for non-radiation-based navigational and localization means toreduce physician exposure to radiation and reduce the amount ofequipment within the operating room. As used herein, the term“localization” may refer to determining and/or monitoring the positionof objects in a reference coordinate system. Technologies such aspre-operative mapping, computer vision, real-time EM tracking, and robotcommand data may be used individually or in combination to achieve aradiation-free operating environment. In other cases, whereradiation-based imaging modalities are still used, the pre-operativemapping, computer vision, real-time EM tracking, and robot command datamay be used individually or in combination to improve upon theinformation obtained solely through radiation-based imaging modalities.

FIG. 20 is a block diagram illustrating a localization system 90 thatestimates a location of one or more elements of the robotic system, suchas the location of the instrument, in accordance to an exampleembodiment. The localization system 90 may be a set of one or morecomputer devices configured to execute one or more instructions. Thecomputer devices may be embodied by a processor (or processors) andcomputer-readable memory in one or more components discussed above. Byway of example and not limitation, the computer devices may be in thetower 30 shown in FIG. 1, the cart shown in FIGS. 1-4, the beds shown inFIGS. 5-14, etc.

As shown in FIG. 20, the localization system 90 may include alocalization module 95 that processes input data 91-94 to generatelocation data 96 for the distal tip of a medical instrument. Thelocation data 96 may be data or logic that represents a location and/ororientation of the distal end of the instrument relative to a frame ofreference. The frame of reference can be a frame of reference relativeto the anatomy of the patient or to a known object, such as an EM fieldgenerator (see discussion below for the EM field generator).

The various input data 91-94 are now described in greater detail.Pre-operative mapping may be accomplished through the use of thecollection of low dose CT scans. Pre-operative CT scans arereconstructed into three-dimensional images, which are visualized, e.g.as “slices” of a cutaway view of the patient's internal anatomy. Whenanalyzed in the aggregate, image-based models for anatomical cavities,spaces and structures of the patient's anatomy, such as a patient lungnetwork, may be generated. Techniques such as center-line geometry maybe determined and approximated from the CT images to develop athree-dimensional volume of the patient's anatomy, referred to as modeldata 91 (also referred to as “preoperative model data” when generatedusing only preoperative CT scans). The use of center-line geometry isdiscussed in U.S. patent application Ser. No. 14/523,760, the contentsof which are herein incorporated in its entirety. Network topologicalmodels may also be derived from the CT-images, and are particularlyappropriate for bronchoscopy.

In some embodiments, the instrument may be equipped with a camera toprovide vision data 92. The localization module 95 may process thevision data to enable one or more vision-based location tracking. Forexample, the preoperative model data may be used in conjunction with thevision data 92 to enable computer vision-based tracking of the medicalinstrument (e.g., an endoscope or an instrument advance through aworking channel of the endoscope). For example, using the preoperativemodel data 91, the robotic system may generate a library of expectedendoscopic images from the model based on the expected path of travel ofthe endoscope, each image linked to a location within the model.Intra-operatively, this library may be referenced by the robotic systemin order to compare real-time images captured at the camera (e.g., acamera at a distal end of the endoscope) to those in the image libraryto assist localization.

Other computer vision-based tracking techniques use feature tracking todetermine motion of the camera, and thus the endoscope. Some features ofthe localization module 95 may identify circular geometries in thepreoperative model data 91 that correspond to anatomical lumens andtrack the change of those geometries to determine which anatomical lumenwas selected, as well as the relative rotational and/or translationalmotion of the camera. Use of a topological map may further enhancevision-based algorithms or techniques.

Optical flow, another computer vision-based technique, may analyze thedisplacement and translation of image pixels in a video sequence in thevision data 92 to infer camera movement. Examples of optical flowtechniques may include motion detection, object segmentationcalculations, luminance, motion compensated encoding, stereo disparitymeasurement, etc. Through the comparison of multiple frames overmultiple iterations, movement and location of the camera (and thus theendoscope) may be determined.

The localization module 95 may use real-time EM tracking to generate areal-time location of the endoscope in a global coordinate system thatmay be registered to the patient's anatomy, represented by thepreoperative model. In EM tracking, an EM sensor (or tracker) comprisingof one or more sensor coils embedded in one or more locations andorientations in a medical instrument (e.g., an endoscopic tool) measuresthe variation in the EM field created by one or more static EM fieldgenerators positioned at a known location. The location informationdetected by the EM sensors is stored as EM data 93. The EM fieldgenerator (or transmitter), may be placed close to the patient to createa low intensity magnetic field that the embedded sensor may detect. Themagnetic field induces small currents in the sensor coils of the EMsensor, which may be analyzed to determine the distance and anglebetween the EM sensor and the EM field generator. These distances andorientations may be intra-operatively “registered” to the patientanatomy (e.g., the preoperative model) in order to determine thegeometric transformation that aligns a single location in the coordinatesystem with a position in the pre-operative model of the patient'sanatomy. Once registered, an embedded EM tracker in one or morepositions of the medical instrument (e.g., the distal tip of anendoscope) may provide real-time indications of the progression of themedical instrument through the patient's anatomy.

Robotic command and kinematics data 94 may also be used by thelocalization module 95 to provide localization data 96 for the roboticsystem. Device pitch and yaw resulting from articulation commands may bedetermined during pre-operative calibration. Intra-operatively, thesecalibration measurements may be used in combination with known insertiondepth information to estimate the position of the instrument.Alternatively, these calculations may be analyzed in combination withEM, vision, and/or topological modeling to estimate the position of themedical instrument within the network.

As FIG. 20 shows, a number of other input data can be used by thelocalization module 95. For example, although not shown in FIG. 20, aninstrument utilizing shape-sensing fiber can provide shape data that thelocalization module 95 can use to determine the location and shape ofthe instrument.

The localization module 95 may use the input data 91-94 incombination(s). In some cases, such a combination may use aprobabilistic approach where the localization module 95 assigns aconfidence weight to the location determined from each of the input data91-94. Thus, where the EM data may not be reliable (as may be the casewhere there is EM interference) the confidence of the locationdetermined by the EM data 93 can be decrease and the localization module95 may rely more heavily on the vision data 92 and/or the roboticcommand and kinematics data 94.

As discussed above, the robotic systems discussed herein may be designedto incorporate a combination of one or more of the technologies above.The robotic system's computer-based control system, based in the tower,bed and/or cart, may store computer program instructions, for example,within a non-transitory computer-readable storage medium such as apersistent magnetic storage drive, solid state drive, or the like, that,upon execution, cause the system to receive and analyze sensor data anduser commands, generate control signals throughout the system, anddisplay the navigational and localization data, such as the position ofthe instrument within the global coordinate system, anatomical map, etc.

2. Introduction to Robotically Assisted Concomitant Procedures

The treatment of certain medical conditions may involve performing twoor more medical procedures to fully treat the medical condition. Forexample, the diagnosis and management of pulmonary lesions may involvemultiple treatment episodes to perform medical procedures includingflexible endoscopy and thoracoscopy. After the discovery of a lesionfrom a radiographic study, such as via analysis of a CT scan, aphysician may perform an endoscopic diagnosis and subsequent therapyover the course of multiple treatment episodes. In one example, if aphysician suspects his or her patient has early stage cancer, thephysician may order that the patient first undergo an endoscopicprocedure for diagnosis of the cancer. During the endoscopic procedure,a nodule may be biopsied and, if the physician determines that removalof the nodule is necessary, the physician may order that patient undergoa second treatment episode for surgical resection of the nodule.

There are drawbacks to performing multiple treatment episodes. Theclinical costs and time demands from both the care givers and patientsare increased for such a multi-episode approach to diagnosing andtreating a condition of the patient. Additionally, during the surgicalresection procedure, a procedure (e.g., endoscopy) may need to berepeatedly performed to aid in accurately localizing the tumor andproviding an operative target for surgical resection. Further, whenstaging medical procedures over multiple treatment episodes, patientsmay have to undergo multiple anesthetic episodes, which can carryincreased risk and inconvenience to patients. And multiple treatmentepisodes may utilize increased perioperative resources (e.g.,preoperative workup, postoperative recovery, and perhaps overnighthospital stays), thereby leading to increased time and costs to both thepatient and the physician.

Rather than staging the medical procedures across multiple treatmentepisodes, the physician has the option of performing multiple proceduresin serial fashion during a single treatment episode. Such a singletreatment episode can be performed by calling upon additional clinicalproviders to assist in performing procedures in parallel as part of thesingle treatment episode.

However, as for multiple treatment episodes, there are drawbacksassociated with single treatment episodes as they are currentlyperformed. As noted above, multiple clinical providers may need toassist in performing a single treatment episode, thereby leading toincreased costs and an overcrowded space in the operating room.Furthermore, to perform multiple procedures serially over a singletreatment episode, the physician may alternate between the variousapproaches, which may involve switching between sterile and non-steriletechniques. Switching between sterile and non-sterile techniques mayfurther involve changing attention from one surgical site to another,regowning, and significantly interrupted clinical workflow.

The coordination of multiple healthcare providers and/or physicians toperform procedures in parallel during a single treatment episode isexpensive and may be cost prohibitive for certain procedures. Oneexample of the use of multiple clinical providers in performing parallelprocedures as part of a single treatment episode is Combined Endoscopicand Laparoscopic Surgery (CELS), which is a manual method of performingcolonic polyp resection. Polyps can be evaluated as to whether they canbe removed endoscopically based on their size, type, and location. Whenpolyps cannot be removed endoscopically, they can be removed viasegmental colectomy, which is accompanied with a comparatively highcomplication rate and increased recovery time. CELS was proposed as amethod to enable extraluminal mobilization of the colon (withlaparoscopic instruments) to make the polyp easier to resectintraluminally (with endoscopic instruments). CELS typically requires atleast two physicians (to control the laparoscopic and endoscopicinstruments respectively) and two assistants (to hold the laparoscopeand colonoscope respectively). While one physician is moving aninstrument, the remaining providers may hold their instruments still,which may be physically demanding over extended periods of time. Theremay be additional staff members in the room to assist with instrumentexchange, pass suture or gauze, handle specimens after removal, andcontrol laparoscopic instruments, etc.

Embodiments of the disclosure relate to systems and methods forperforming two or more types/modes of procedures concomitantly (e.g., bya single user or team) as part of a single treatment episode. Thesystems and methods described herein improve upon the single andmultiple treatment episodes described above. In some embodiments,parallel procedures can be performed as part of a single treatmentepisode with the aid of a novel robotic medical system, thereby reducingthe need to have as many healthcare providers and/or physicians as withnon-robot assisted parallel medical procedures, such as, e.g., existingCELS.

In addition to the above example of endoscopic diagnosis and surgicalresection of a cancerous tumor, other example medical procedures maybenefit from the systems and methods described herein, includingbronchoscopic localization of lung cancer with simultaneousthoracoscopic resection, endoscopic localization of gastrointestinalcancer with laparoscopic resection, endoscopic localization andresection of gastrointestinal cancer with laparoscopic assistance,endoscopic imaging or visualization for gastrointestinal reconstructiveprocedures, such as gastrectomy, roux-en-y-gastric bypass, etc.,ureteroscopic stone/tumor localization and percutaneousremoval/resection. In some embodiments, such procedures can be performedin a single treatment episode. In some embodiments, such procedures canbe performed with a minimal number of clinicians, and in some cases, asingle physician. Furthermore, in some embodiments, simultaneousprocedures can be performed using a single type of console to controlthe simultaneous procedures.

In accordance with aspects of this disclosure, a first type of procedureperformed during concomitant/parallel medical procedures can involvedelivering one or more flexible devices into a patient, while a secondtype of procedure can involve delivering one or more rigid devices intothe patient. For example, in one embodiment, the two concomitantprocedures can involve an endoscopic procedure (e.g., using a flexiblescope) in combination with a laparoscopic procedure (e.g., using a rigidscope). In a medical treatment involving a tumor in the bronchial tract,a first endoscopic tool (e.g., a flexible bronchoscope) can be insertedthrough the bronchial tract, while a second laparoscopic tool (e.g., arigid camera or a cutter) can be inserted through an incision thatprovides access to the tumor.

In some embodiments, the first type of procedure can be performedthrough a natural orifice while the second type of procedure can beperformed through an incision. For example, in a medical procedureinvolving the removal of kidney stones, a first tool (e.g., a laser) canbe inserted through the natural orifice of the urethra to break up thestones in the renal pelvis, while a second tool (e.g., a vacuum) can beinserted percutaneously through an incision to suction and remove thebroken kidney stones.

A. Systems and Methods for Performing Concomitant Procedures.

In some embodiments, a single robotic medical system can perform two ormore types of medical procedures concomitantly as part of a singletreatment episode. FIG. 21 illustrates an embodiment of a bed-basedrobotic system configured for performing concomitant procedures inaccordance with aspects of this disclosure. As shown in FIG. 21, therobotic medical system 200 includes a first set of one or more roboticarms 205 and a second set of one or more robotic arms 210. The system200 further includes a platform 215, which may include a bed onto whicha patient can be positioned, with the first and second sets of roboticarms 205 and 210 positioned on bilateral arm supports or rails withrespect to the platform 215. The first set of robotic arms 205 may becoupled to a first adjustable arm support 220 while the second set ofrobotic arms 210 may be coupled to a second adjustable arm support 225,located on an opposing side of the platform 215 with respect to thefirst adjustable arm support 220. The bed of the platform 215 mayinclude a head portion and a foot portion. The first arm support 220 andthe second arm support 225 may be positioned in between the head portionand the foot portion.

In certain embodiments, the first set of arms 205 may be configured tocontrol one or more flexible instruments 230, such as, e.g., acolonoscope, bronchoscope or ureteroscope (e.g., having an inner andouter catheter), as part of an endoscopic procedure. The second set ofarms 210 may be configured to control one or more rigid instruments 235,such as a rigid camera, vessel sealers, tissue cutters, staplers, needledrivers, etc., as part of a laparoscopic procedure. In the presentembodiment, the first set of arms 205 are aligned in a virtual rail todeliver a flexible ureteroscope in accordance with some embodiments. Thesecond set of arms 210 deliver one or more laparoscopic instrumentsthrough laparoscopic ports. In some embodiments, at least one of thelaparoscopic instruments can be rigid, although in some embodiments, thesecond set of arms 210 can be configured to deliver a combination ofrigid and flexible instruments, such as a rigid cutter and a flexiblearticulating laparoscope. As shown in FIG. 21, the first set of arms 205is configured to approach the patient from a direction that is differentfrom the second set of arms 210. For example, the first set of arms 205can approach the patient from a base of the platform 215, while thesecond set of arms 210 can approach the patient from a side of theplatform 215. In some embodiments, one or more of the endoscopic orlaparoscopic instruments can be navigated in part or wholly via EM orfluoroscopic navigation. In some embodiments, the first set of arms 205is capable of being locked while the second set of arms 210 is moveable.In other embodiments, the first set of arms 205 is moveable while thesecond set of arms 210 is locked.

As shown in the FIG. 21 the first set of arms 205 is coupled to thefirst adjustable arm support 220, while the second set of arms 210 iscoupled to the second adjustable arm support 225. The first adjustablearm support 220 can be independently adjustable from the secondadjustable arm support 225. In some embodiments, the first adjustablearm support 220 is at a height that is different from the secondadjustable arm support 225, while in other embodiments, the firstadjustable arm support 220 is at a height that is the same as the secondadjustable arm support 225. In some embodiments, the arm supports 220,225 and/or the arms 205, 210 can be stowed beneath the platform 215. Insome embodiments, one or more of the arm supports 220, 225 and/or thearms 205, 210 can be elevated above a base of the platform, therebyavoiding “mop slop” and inadvertent dirt from getting on thesecomponents. In some embodiments, one or more arm supports 220, 225and/or the arms 205, 210 can be elevated from a stowed position to aheight that is higher than a top surface of the bed or platform 215.

In the present embodiment, a pair of arms 205 are coupled to the firstadjustable arm support 220, while a trio of arms 210 are coupled to thesecond adjustable arm support 225. In other embodiments, the number ofarms on each of the adjustable arm supports can be even. In otherembodiments, the number of arms can be greater or less than the numberof arms shown in FIG. 21.

FIG. 22 illustrates another embodiment of a bed-based robotic systemconfigured for performing concomitant procedures in accordance withaspects of this disclosure. Similar to the embodiment of FIG. 21, theembodiment illustrated in FIG. 22 includes a first set of one or morerobotic arms 205, a second set of one or more robotic arms 210, aplatform 215 with the plurality of robotic arms 205 and 210 positionedon bilateral arm supports with respect to the platform 215. Thesebilateral arm supports include a first adjustable arm support 220, and asecond adjustable arm support 225.

In contrast to the embodiment illustrated in FIG. 21, in the FIG. 22embodiment, the first set of robotic arms 205 comprises a single roboticarm that is configured to control a rigid laparoscopic instrument 235percutaneously through a patient while the second set of robotic arms210 comprises a pair of robotic arms that are configured to control aflexible endoscopic instrument 230. In other embodiments, the roboticarms 205 and 210 may be located on the same side of the bed (or adjacentsides of the bed) and may be configured to control a flexible endoscopicinstrument 230 and a rigid laparoscopic instrument 235, respectively. Instill other embodiments, a set of robotic arms 205 and 210 including atleast one arm located on each side of the platform 215 may be configuredto control a first medical instrument (e.g., a flexible endoscopicinstrument 230), which another set of robotic arms 205 and 210 includingat least one arm located on each side of the platform 215 may beconfigured to control a second medical instrument (e.g., a rigidlaparoscopic instrument 235).

In each of the embodiments illustrated in FIGS. 21 and 22, a singlebed-based system having robotic arms attached thereto can be configuredto perform both an endoscopic procedure involving one or more flexibleinstruments 230, as well as a laparoscopic procedure involving one ormore rigid instruments 235. The endoscopic procedure can be performedthrough a natural orifice (e.g., a throat), while the laparoscopicprocedure can be performed through an incision (e.g., a chest). Theprocedures can advantageously be performed concurrently/concomitantly(partially or wholly) via a single console (additional details of whichare provided below) by a single user. In some embodiments, the roboticmedical system 200 can be configured to perform two types of medicalprocedures in series as well if desired. For example, a first type ofprocedure may be performed on a patient. If such a procedure isineffective on its own, a second type of procedure can be performed toovertake or supplement the first type of procedure as part of a“procedure escalation.”

In each of FIGS. 21 and 22, the robotic arms 205 and 210 can be stowedand subsequently deployed from underneath the platform 215. The roboticarms 205 and 210 are configured to be positioned in multiple locationse.g., near a patient's 240 feet and/or near a patient's 240 right sidebased on commands received from a user. The robotic arms 205 and 210 areconfigured to be translatable along the adjustable arm supports 220 and225. The robotic arms 205, 210 are capable of multiple degrees offreedom, including two, three, four, five, six, seven, eight or greater.In some embodiments, the robotic arms 205, 210 include one or moreredundant degrees of freedom. The robotic arms 205, 210 are coupled toadjustable arm supports 220, 225 that are configured to providevertical, lateral, and longitudinal adjustment of the robotic arms 205and 210. Independent of the movement of the robotic arms 205 and 210, insome embodiments, the adjustable arm supports are configured to beadjusted in three degrees of freedom. In certain embodiments, theadjustable arm supports 220 and 225 may be in the form of bars or rails,along which the bases of the robotic arms can translate. The bases maycouple the robotic arms 205 and 210 to the adjustable arm supports 220and 225.

Referring to the specific configuration of the robotic systemillustrated in FIG. 21, the first adjustable arm support 220 has beenadjusted horizontally such that it extends below and beyond a base ofthe platform 215, thereby allowing the first robotic arms 205 to bepositioned near the patient's 240 feet as part of an endoscopicprocedure. The second adjustable arm support 225 has been keptsubstantially aligned with the platform 215, but has been adjustedvertically such that the second robotic arms 210 attached thereto can bepositioned above the patient 240 as part of a laparoscopic procedure.The first and second adjustable arm supports 220 and 225 allow therobotic arms 205 and 210 to approach from different directions,including different heights and lateral positions.

Although the robotic arms 205 and 210 have been described as dividedinto a first set of robotic arms 205 and a second set of robotic arms210, the robotic arms 205 and 210 can be divided into other groupings(including sets of one or more arms), each configured to perform adistinct procedure as part of a concomitant medical procedure. In someembodiments, a concomitant procedure (e.g., for diagnosis) can beperformed with as few as two arms—one to hold a flexible camera, theother to hold an instrument. In some embodiments, a concomitantprocedure (e.g., for treatment) can be performed with two arms or threearms. In some embodiments, four or more robotic arms 205 and 210 can beprovided.

Depending on the combination of medical procedures being performedconcomitantly, the robotic arms 205 and 210 can be configured and/oroperated to control various medical instruments. Examples of uses forwhich one or more of the robotic arms 205 and 210 can be implementedusing the robotic medical system 200 include: (i) a robotic armconfigured to control an introducer or sheath which provides access to anatural body orifice, such as, e.g., the nose, mouth, vagina, urethra,rectum, or ear; (ii) a robotic arm configured to control an endoscopeand/or endoscopic instrumentation (e.g., a flexible instrument) througha natural orifice into the body, with or without the aforementionedintroducer or sheath; (iii) a robotic arm configured to hold and commanda thoracoscopic or laparoscopic camera (e.g., a flexible or rigiddevice) which provides extraluminal visualization in the relevantanatomic space (e.g., thoracic, abdominal, extra-peritoneal, and/orretro-peritoneal space); and/or (iv) one or more robotic arms configuredto hold and command thoracoscopic or laparoscopic instrumentation (e.g.,a rigid device). These are just exemplary uses, and one skilled in theart will appreciate that the systems described herein are not limited tothese practices.

There are a number of advantages in using a single system such as therobotic medical system of one of FIGS. 21 and 22 to perform concomitantendoscopic and laparoscopic procedures with flexible and rigid tools.First, the use of a single system conserves the amount of space occupiedby the components of the system by having less equipment/capital in theoperating room. Second, the use of a single system makes it easier for asingle clinician/physician to perform both types of procedures withoutthe aid of other clinicians/physicians within the operating room. Andthird, with the use of a single system, each of the roboticallycontrollable components of the system may be tied to the same globalreference frame—e.g., position(s) and/or orientation(s) of theendoscopic instrument(s) can be easily referenced relative toposition(s) and/or orientation(s) of the laparoscopic instrument(s). Inother words, a single system provides knowledge of positional and/ororientation-related data for all instruments and manipulators relativeto a single coordinate frame, thereby enabling features such ascollision prevention and/or avoidance, and/or computer-generateddisplays of instruments with respect to each other.

FIG. 23 illustrates yet another embodiment of a robotic systemconfigured for performing concomitant procedures in accordance withaspects of this disclosure. The robotic medical system 300 includes botha platform-based robotic system 301 and a cart-based robotic system 303.The platform-based robotic system 301 includes a first set of one ormore robotic arms 305, a second set of one or more robotic arms 310, anda bed or platform 315, wherein the plurality of robotic arms 305 and 310are positioned bilaterally with respect to the platform 315. The system300 further includes a first adjustable arm support 320 coupled to thefirst set of one or more robotic arms 305, and a second adjustable armsupport 325 coupled to the second set of one or more robotic arms 310.The cart-based robotic system 303 includes a third set of one or morerobotic arms 330 coupled to a third adjustable arm support 335. In thepresent embodiment, the platform-based robotic system 301 and thecart-based robotic system 303 are advantageously integrated to performconcomitant procedures as part of a single treatment episode.

The first and second sets of robotic arms 305 and 310 are configured tocontrol one or more rigid instruments 340, such as, e.g., a camera,vessel sealers, tissue cutters, staplers, needle drivers, etc., as partof a laparoscopic procedure performed on a patient 350. The third set ofrobotic arms 330 are configured to control one or more flexibleinstruments 345, such as, e.g., a colonoscope, bronchoscope orureteroscope (e.g., having an inner and outer catheter), as part of anendoscopic procedure. However, in other configurations, any combinationor subset of the first, second, and third robotic arms 305, 310, and 330may be configured to control a rigid instrument 340 and/or a flexibleinstrument 345. In some embodiments, the robotic system 300 may includetwo or more cart-based systems 303, each of which may be configured tocontrol one or more medical instruments.

FIGS. 24 and 25 illustrate two configurations of another embodiment of abed-based robotic system configured for performing concomitantprocedures in accordance with aspects of this disclosure. As shown inFIGS. 24 and 25, the robotic medical system 400 includes a first set ofone or more robotic arms 405, a second set of one or more robotic arms410, a platform 415, an adjustable arm support 420, one or more flexiblemedical instruments 425, and one or more rigid medical instruments 430.In the present embodiment, the first set of one or more robotic arms 405and the second set of one or more robotic arms 410 share the sameadjustable arm support 420. An imaging device (e.g., CT, fluoroscopic,etc.) is positioned on a side of the platform 415 opposite the armsupport 420. The system 400 further includes an electromagnetic fieldgenerator 418 for assisting in navigation of one or more instruments viaEM sensor.

In a first configuration of the robotic medical system shown in FIG. 24,the first set of robotic arms 405 can be configured to control aflexible medical instrument 405 to be inserted through a patient's 440bronchial tract. The second set of robotic arms 410 can be stowed belowthe platform 415 without controlling a medical instrument. In a secondconfiguration shown in FIG. 25, the first set of robotic arms 410 can beconfigured to control the flexible instrument 425 while the second setof robotic arms 410 have been elevated from the stowed position tocontrol one or more rigid instruments 430, which can be inserted throughan incision formed in the patient 440. The robotic arms can be elevatedvia the adjustable arm supports 420. As shown in FIG. 25, an arm rest422 can be coupled to the platform and/or one or more of the adjustablearm supports 420 to allow a patient's arm to rest during a procedure. Ascan be seen in FIGS. 24 and 25, different subsets of the robotic arms405 and 410 can be selected to control the medical instruments 425 and430 depending on how the robotic medical system 400 is configured orutilized. In particular, two robotic arms 405 may be included as part ofthe first set of robotic arms 405 to control the flexible instrument inthe configuration of FIG. 24, while a single robotic arm 405 can beincluded as part of the first set of robotic arms 405 to control theflexible instrument in the configuration of FIG. 25. As shown in FIGS.24 and 25, different combinations of robotic arms 405, 410 on a givenadjustable arm support 420.

FIG. 26 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for performing at leastpartially or wholly concomitant medical procedures in accordance withaspects of this disclosure. For example, the steps of method 500illustrated in FIG. 26 may be performed by processor(s) and/or othercomponent(s) of a medical robotic system (e.g., robotically-enabledsystem 10, or one of the robotic medical systems 200, 300, or 400discussed above) or associated system(s). For convenience, the method500 is described as performed by the “system” in connection with thedescription of the method 500.

The method 500 begins at block 501. At block 505, the system may controla first robotic arm to insert a first medical instrument through a firstopening of a patient. At block 510, the system may control a secondrobotic arm to insert a second medical instrument through a secondopening of the patient. The first robotic arm and the second robotic armmay be part of a first platform and the first opening and the secondopening may be positioned at two different anatomical regions of thepatient. The method 500 ends at block 515.

As an example implementation of the method 500 and with reference to theembodiment of FIG. 21, at block 505 the robotic medical system 200 maycontrol the first set of robotic arms 205 to insert the flexible medicalinstrument 230 through a first opening of the patient 240. Similarly, atblock 510 the robotic medical system 200 may control the second set ofrobotic arms 210 to insert the rigid medical instrument 230 through asecond opening of the patient 240. In some embodiments, the firstopening may be a natural orifice of the patient and the second openingmay be an incision formed in the patient.

In some embodiments, the first medical instrument can comprise a firstimage capture device (e.g., an endoscope) and the second medicalinstrument can comprise a second image capture device (e.g., alaparoscope). By inserting the first and second medical instruments(each having a camera or other imaging component) through differentopenings positioned at two different anatomical regions of the patient,it is possible to provide different views of one or more anatomicalregions of the patient. For example, when the flexible instrument isinserted through the patient's colon and the rigid instrument isinserted into the patient's abdominal cavity, the flexible instrumentmay be able to provide a view of a colon polyp from within the colon,while the rigid instrument may be able to provide a view of the samecolon polyp from the abdominal cavity (e.g., from exterior of thecolon). The system described herein advantageously allows a user toswitch between the different camera views when viewing a display. Insome embodiments, a view from the first image capture device can beoverlaid on a view from the second image capture device on a display. Insome embodiments, a view of the first image capture device can be placedside-by-side with the second image capture device in a tiled view on adisplay. Additional details regarding camera view manipulation aredescribed below.

Aspects of this disclosure, including the method 500 of FIG. 26, mayenable standalone endoscopic procedures, percutaneous procedures,laparoscopic procedures, as well as simultaneous combinations thereof.When utilizing all three modalities during a single procedure, a subsetof one or more robotic arms can be allocated to drive and controlflexible endoscopes and instrumentation to provide direct visualizationand access to lumens in the body, another subset of one or more roboticarms can be allocated to drive and control laparoscopic/thoracoscopiccameras to provide direct visualization inside of various body cavities,while another subset of one or more robotic arms can be allocated todrive and control rigid, semi-rigid, or flexible instrumentation insideof a body cavity. The robotic arms can be configured and deployed asneeded for any case.

FIGS. 27A and 27B provide a flowchart illustrating another examplemethod operable by a robotic system, or component(s) thereof, forperforming concomitant endoscopic and thoracoscopic procedures inaccordance with aspects of this disclosure. For example, the steps ofmethod 600 illustrated in FIGS. 27A and 27B may be performed byprocessor(s) and/or other component(s) of a medical robotic system(e.g., robotically-enabled system 10, or one of the robotic medicalsystems 200, 300, or 400) or associated system(s). For convenience, themethod 600 is described as performed by the “system” in connection withthe description of the method 600.

The method 600 begins at block 601. At block 605, a bed-based platformmay be configured to receive a patient, transferred onto the bed byoperating room staff. At block 610, the system may deploy first armseither from the bed or an integrated cart-based system in preparationfor an endoscopic instrument. At block 615, the first robotic armsreceive a flexible instrument, which may be loaded onto the firstrobotic arms by operating room staff. At block 620, under control of aphysician, the system may drive the flexible instrument into the patientvia a natural bodily orifice.

At block 625, the system may localize a target pathology using theflexible instrument. In the case of pulmonary lesions, blocks 620 and625 may involve introducing the flexible instrument into the airway anddriving the flexible instrument, under control of the physician, to thetarget (e.g., a lesion of interest).

At block 630, the system may deploy second robotic arms to performlaparoscopic resection. In some embodiments, block 630 may be performedin response to a determination that the pathology is cancerous. At block645, the second robotic arms may receive thoracoscopic instruments,which may be loaded onto the first robotic arms by operating room staff.The operating room staff may also create thoracoscopic ports throughwhich the thoracoscopic instruments are configured to be inserted intothe patient. The thoracoscopic instrument may include a rigid camera, inthis case a thoracoscope, and thoracoscopic instruments. Thethoracoscopic ports may comprise cannulas which provide access to thepatient's thoracic cavity.

At block 640, the system may perform laparoscopic resection of thetarget using the thoracoscopic instruments under control of thephysician. The flexible instrument and the thoracoscope may provideseparate views of the target from inside and outside of the airway,respectively, aiding the physician in performing the resection. Onceresection is complete, the physician and/or operating room staff mayremove the thoracoscopic instruments and close thoracoscopic ports andremove flexible device from the patient. The method 600 ends at block645.

B. Procedure Escalation.

One benefit of the ability to control both endoscopic and laparoscopicinstruments from a single platform (or a hybrid bed-based platform andcart-based system) is the ability to escalate the level of invasivenessof a surgical procedure as needed. Different procedures have differentdegrees of invasiveness. For example, a first type of procedure can be apurely endoscopic resection. A second type of procedure can be anendoscopic resection with laparoscopic assistance. And a third type ofprocedure can be a laparoscopic resection. The systems and methodsdescribed herein can advantageously enable a physician to escalate aprocedure from one type of procedure to another with ease, such as fromthe first type of procedure to the second type of procedure, the secondtype of procedure to the third type of procedure, or from the first typeof procedure to the third type of procedure.

In some embodiments, a physician may intend to perform the first type ofprocedure (e.g., purely endoscopic resection) and escalate treatment toinclude the second type of procedure (e.g., endoscopic resection withlaparoscopic assistance). In some embodiments, the first type ofprocedure can be less invasive than the second type of procedure. Forexample, in the first type of procedure, a physician can attempt toperform a resection endoscopically without having to form an incision ina patient. In the second type of procedure, the degree of invasivenessincreases as ports and holes are introduced in a patient's abdomen inorder to provide laparoscopic assistance. The ports and holes can beprovided to introduce a laparoscope and/or other laparoscopicinstruments for e.g., viewing tissue and positioning; however, theresection is still endoscopic, which keeps complication rates andrecovery time relatively minimal. The systems and methods describedherein can advantageously enable a physician to escalate a procedurefrom the first type of procedure to the second type of procedure withease.

In some embodiments, a physician may intend to perform the second typeof procedure (e.g., endoscopic resection with laparoscopic assistance)and escalate treatment to include the third type of procedure (e.g.,laparoscopic resection). In some embodiments, the second type ofprocedure can be less invasive than the third type of procedure. Forexample, in the second type of procedure, a physician can attempt toperform an endoscopic resection with laparoscopic assistance. In thethird type of procedure, the degree of invasiveness increases as theresection is performed laparoscopically. Such a resection, such as asegmental colectomy, can involve higher risk and recovery time relativeto the first and second types of procedures. The systems and methodsdescribed herein can advantageously enable a physician to escalate aprocedure from the second type of procedure to the third type ofprocedure with ease.

One example treatment for which procedure escalation may be performed iscolon polyp resection. A physician can begin a treatment by attempting apurely endoscopic resection of a colon polyp. If the purely endoscopicresection fails, the physician can quickly escalate to perform anendoscopic resection of the colon polyp with the assistance oflaparoscopic instruments. In some embodiments, the escalation can beperformed without bringing additional personnel or capital equipmentinto the room. If the endoscopic resection is still inadequate forresection despite the aid of laparoscopic instruments, the physician canescalate the procedure to a fully laparoscopic procedure and pursue alaparoscopic resection. In this example, performing an endoscopicresection with the assistance of laparoscopic instruments may have ahigher level of invasiveness than performing a pure endoscopicresection, while performing a laparoscopic resection may have a higherlevel of invasiveness than performing an endoscopic resection with theassistance of laparoscopic instruments. The level of invasiveness of agiven procedure may be determined based on numerous factors, includingbut not limited to the desired or expected recovery time of the patient,the absence or presence of an incision to deliver instrumentation, thesize of an incision required to deliver the medical instruments into thepatient's body, the expected morbidity after a procedure, the expectedcomplication risk, etc.

By performing a treatment using procedure escalation, a physician canattempt to perform the least invasive procedure first, before attemptingto perform more invasive procedures. For example, by treating the colonpolyp using procedure escalation, the physician may advantageously beable to resect some or all of the colon polyp using a full endoscopicresection, before possibly moving on to more invasive procedures,thereby potentially reducing the associated recovery times for thepatient without extending treatment over multiple episodes. Althoughprocedure escalation is described above in connection with a colon polypexample, procedure escalation can be applied to other medical proceduresincluding, for example, the diagnosis and resection of cancerousnodules.

FIG. 28 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for performing concomitantmedical procedures including procedure escalation in accordance withaspects of this disclosure. For example, the steps of method 700illustrated in FIG. 28 may be performed by one or more processor(s)and/or other component(s) of a medical robotic system (e.g.,robotically-enabled system 10, or one of the robotic medical systems200, 300, or 400) or associated system(s). For convenience, the method700 is described as performed by the “system” in connection with thedescription of the method 700.

The method 700 begins at block 701. The method 700 may be performedduring the method 500 for performing concomitant medical proceduresillustrated in FIG. 26, for example, between blocks 505 and 510.However, the timing of performing the method 700 is not limited, and maybe performed before block 505, after block 510, or concurrently with oneor more of blocks 505 and 510. At block 705, the system may control thefirst robotic arm to perform a first medical procedure. The firstmedical procedure may involve localizing the target site. The system mayfurther select a site for an incision based on the localization of thetarget site. The incision may be used for delivering the second medicalinstrument used in the second medical procedure of block 710.

At block 710, in response to a determination that the first medicalprocedure has failed to fully treat a medical condition of the patient,the system may control the second medical procedure to perform a secondmedical procedure to fully treat the medical condition of the patient.The second medical procedure may have a higher level of invasivenessthan the first medical procedure. The first medical procedure and thesecond medical procedure are performed concomitantly during a singlemedical episode. In some embodiments, the first medical procedure andthe relatively more invasive second medical procedure are performedusing a single platform, such as a cart-based platform or a bed-basedplatform with multiple arms. In other embodiments, the first medicalprocedure and the relatively more invasive second medical procedure areperformed using multiple integrated platforms, such as a bed-basedplatform in combination with a cart-based platform or a cart-basedplatform in combination with another cart-based platform. In someembodiments, the system may further control the second robotic arm toperform the second medical procedure in response to a determination thata target site within an anatomy of the patient satisfies a condition fortreatment via the second medical procedure. The method 700 ends at block715.

C. User Interface for the Control of Multiple Medical Instruments.

Another aspect of this disclosure relates to a user interface which canenable a single user to control all of the robotic arms during aconcomitant procedure. In other words, aspects of this disclosure relateto the use of a novel single interface which can be used to perform anendoscopic intervention using one or more flexible devices, as well as alaparoscopic intervention using one or more rigid devices.

FIG. 29 illustrates an example console including one or more types ofinterfaces for controlling robotic arms in accordance with aspects ofthis disclosure. As shown in FIG. 29, the console 800 includes a viewer805, a controller 810 including two handles (also referred to aspositioning platforms) 815, configured to received input from a user'sleft and right hands, a pendant 820, an armrest 825, and one or morefoot pedals 830.

FIG. 30 illustrates a close-up view of the controller illustrated inFIG. 29 in accordance with aspects of this disclosure. The controller810 of FIG. 30 may be similar to the controller 182 illustrated in FIG.19. FIG. 31 illustrates a close-up view of one of the handlesillustrated in FIGS. 29 and 30 in accordance with aspects of thisdisclosure. In some embodiments, the handle 815 includes a button 835and finger-grips 840. The button 835 provides a user interface whichallows the user to actuate an end effector of the corresponding medicalinstrument. The finger-grips 840 may provide an interface which allowsthe user to grab the handle 815 and manipulate the position of thehandle 815 in six degrees of freedom. The handle 815 may also functionas a gimbal allowing the user to manipulate the handle in the threeorientation degrees of freedom (e.g., pitch, yaw, and roll).

FIG. 32 illustrates a close-up view of the pendant illustrated in FIG.29 in accordance with aspects of this disclosure. The pendant 820includes an insert/retract joystick 845, a menu button 850, a quickaction button 855, a pause button 860, an articulate and relax joystick865, snapshot, light, and one-programmable buttons 870, and a fivebutton cluster button 875. The pendant 820 may be configured to drive aflexible instrument, such as the flexible instruments 230 of FIG. 21.

Although FIGS. 29-32 include two or more types of user interfaces (e.g.,a gimbal-based interface and a pendant-based interface), in someembodiments, the console 800 may include a single type of interface,such as the handles 815 to perform the concomitant procedures disclosedherein. For example, in some embodiments, the left-hand handle 815 canbe configured to control an endoscopic instrument while the right-handhandle 815 can be configured to control a laparoscopic instrument. Inother embodiments, the left- and right-hand handles 815 can be used intwo different modes—a first mode configured to control one or moreflexible endoscopic instruments and a second mode configured to controlone or more rigid laparoscopic instruments. The foot pedal 830 or otherbutton on the console 800 may be configured to receive an input from theuser to switch between the two modes. The use of a single type ofinterface to control two different instruments (e.g., a flexibleendoscope and a rigid laparoscope) is highly novel, as a physician wouldoften use two different types of interfaces to control such variedinstrumentation.

While a controller 810 such as the controller 810 of FIG. 30 having leftand right hand handles 815 may be used for controlling laparoscopicinstruments, it may not be typical to use this type of controller 810with concomitant endoscopic procedures involving one or more flexibledevices. However, it may be desirable to provide a single user interfaceto the user to control two or more medical instruments (including anendoscopic instrument and laparoscopic instrument) through the sameinterface, so that the user does not have to continually switch betweendifferent user input device when switching between control of the twomedical instruments. Thus, in order to provide a single interfacethrough which the physical can control both, the controller 810 may beadapted to control an endoscopic instrument in addition to thelaparoscopic instrument.

FIG. 33 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for performing concomitantmedical procedures via a single user interface in accordance withaspects of this disclosure. For example, the steps of method 900illustrated in FIG. 33 may be performed by processor(s) and/or othercomponent(s) of a medical robotic system (e.g., robotically-enabledsystem 10, or one of the robotic medical systems 200, 300, or 400) orassociated system(s). For convenience, the method 900 is described asperformed by the “system” in connection with the description of themethod 900.

The method 900 begins at block 901. At block 905, the system may use auser interface to operate a first instrument inserted through a firstopening of a patient via a first robotic arm. At block 910, the systemmay use the user interface to operate a second instrument insertedthrough a second opening of the patient via a second robotic arm. Thefirst opening and the second opening are positioned at two differentanatomical regions of the patient. In some embodiments, the firstopening may be a natural orifice of the patient and the second openingmay be an incision formed in the patient. The first instrument may beflexible, while the second instrument may be rigid. The method 900 endsat block 915.

In one embodiment, in response to the system received a selection from auser for control of endoscopic instruments, one of the handles 815 ismapped to control of insertion and retraction of the endoscopicinstruments, while the other handle 815 is mapped to control of thearticulation and roll of the endoscopic instrument. The handle 815controlling insertion and retraction may be haptically constrained tomove in a line and the controller 810 may include a clutch configured toallow the user to adjust the stroke length available to translate theendoscopic instrument into or out of the patient's body. The handle 815controlling articulation and roll can be haptically constrained so thatthe handle 815 does not move in a planar fashion. The position of theother articulation/roll handle 815 can be fixed in a coordinate planebut allowed to rotate, pitch, and yaw. Accessory buttons 835 on thearticulation/roll handle 815 can be configured to allow the user toirrigate or aspirate a lumen, as well as to deliver energy to theendoscopic instrument.

In a second embodiment, one of the handles 815 can be mapped to controlof insertion and retraction of the endoscopic instruments, while theother handle 815 is mapped to control of the articulation and roll ofthe endoscopic instrument as in the first embodiment, but the drivingexperience for the user may be modified slightly. One handle 815 may behaptically constrained to move in a line, but rather than requiring theuser to clutch, the user controller 810 may be configured such that theuser simply moves his or her hand away or toward the procedural targetthus translating the endoscopic instrument away from or toward a pointof interest. The magnitude with which the user moves his or her hand canbe mapped to the velocity with which the endoscopic instrumenttranslates into or out of the patient's body. The remaining handle 815may be configured to be controlled in similar fashion as described inthe first embodiment.

A third embodiment may include the controller 810 having a secondary setof interfaces (not illustrated) in addition to the primary handles 815illustrated in FIGS. 29-31. The primary left and right handles 815 canbe configured similar to laparoscopic or thoracoscopic controlinterfaces. The secondary set of left and right interfaces can beconfigured to drive endoscopic instruments. One of the secondaryinterfaces can include a loop of endoscope-like insertion tube mountedon two wheels. The loop of insertion tube can be configured to betranslated along an axis and rolled left and right. The insertion tubecan provide either positional or velocity based controls. There may be atoggle button on the controller 810 to allow the user to cycle throughconcentric instruments that need to be translated or rolled in thepatient's body. Another secondary interface can include a mock endoscopetip that is enhanced with a series of buttons. The mock endoscope tipcan be configured to be manipulated by the user to command the desiredshape of the distal end of the robotic controlled endoscopic instrument.Buttons on the mock endoscope tip can be utilized to irrigate oraspirate within a lumen, as well as deliver energy to the endoscopicinstrument. The mock endoscope tip may either assume the currentposition of endoscopic instrument being controlled and maintain thatposition until commanded otherwise by the user, or behave more like atraditional endoscopic instrument and only maintain a position whenactively commanded by the user. Another secondary interface can includea “joy-stick” type button on one or more of the handles 815, which canbe used to control one or more flexible instruments in a similar fashionto the inputs on pendant 820. In some embodiments, the handles 815reposition themselves into an alternative configuration (e.g., such aspointing upwards) to facilitate ergonomic control of the secondaryinterface joystick buttons.

In a fourth embodiment, the controller 810 may include secondaryinterfaces to translate and roll the endoscopic instrument as describedin the third embodiment, but one of two primary left or right handinterfaces can be configured to control endoscopic instrumentarticulation and other functions.

In a fifth embodiment, the controller 810 can include secondaryinterfaces which include a pendant 820 as shown in FIG. 32. In thisembodiment, the user must physically switch back and forth between theleft and right handle 815 surgical controls, and the pendant 820 to movebetween control of laparoscopic and endoscopic instruments. The currentview displayed by the viewer 805 can be controlled by the controller810.

In some embodiments, the console 800 is configured to restrict thenumber of robotic arms controllable by the simultaneously whileconstraining the motion of the other robotic arms. For example, in someembodiments, the interfaces can be used to drive a selected robotic arm,while constraining the motion of the other robotic arms (e.g., two,three, four or more).

D. Viewing and Switching Image Displays.

With reference to FIGS. 29-32, in some embodiments, the viewer 805 canbe configured to display images from endoscopic and laparoscopic imagingsensors, as well as any preoperative plans or scans that have beenloaded onto the system or other sources of live video such as anultrasound probe. The user can toggle between the different views invarious ways, including but not limited to: using the accessory button835 located on left or right hand interfaces; using the accessory footpedal 830 or a switch activated by the user's feet, knees, toes orelbow; using haptic enabled commands in combination with instrumentclutching to toggle or cycle between multiple views using hand-basedgestures via left and right hand interfaces; using the control pendant825 attached to the console; or any combination. Secondary views may bedisplayed via picture-in-picture, side-by-side, split frame, or cyclicalviewing modes.

FIGS. 34 and 35 are example views which may be displayed by a viewerduring concomitant medical procedures in accordance with aspects of thisdisclosure. In particular, FIG. 34 illustrates a thoracoscopic view 1000while FIG. 35 illustrates an endoscopic view 1050.

In some embodiments, the control of the currently selected medicalinstrument is synchronized with the coordinate frame of the primary viewdisplayed by the viewer 805. The system may consider the instrumentsoriginating from the approach of the primary view displayed as theprimary instruments, however, the system may allow the user to controlany instrument on the system relative to the primary view. In otherwords, in the scenario where the user is in the thoracoscopic viewingmode 1000, the thoracoscopic instruments are the primary instruments. Asshown in the thoracoscopic viewing mode 1000 of FIG. 34, a firstthoracoscopic instrument 1005 and a second thoracoscopic instrument 1010can be seen.

The user may want to adjust the endoscope that is positioned within thelung. To do so, the user may display the appropriate secondary view (inthis case endoscopic view 1050), and utilize one of the interfacesdescribed above in “Section C.” to toggle from a primary left or righthand instrument to a secondary left or right hand instrument, and adjustendoscopic instruments as necessary. As shown in FIG. 35, the endoscopicview 1050 may include a first view 1055 of a camera on the endoscope anda second view 1060 illustrating the position of the tip of the endoscopewith respect to a preoperative model. In addition to toggling betweenthe thoracoscopic view 1000 and the endoscopic view 1050, the system mayfurther be able to toggle between the thoracoscopic view 1000, theendoscopic view 1050, and a third view obtained via a pre-operative scanof the patient.

FIG. 36 is another example view which may be displayed by a viewerduring concomitant medical procedures in accordance with aspects of thisdisclosure. In some embodiments, the system may be configured to have acomputer-generated overlay of one image on top of another, as shown inFIG. 36. In fact, in the embodiment illustrated in FIG. 36, two separateview-on-view embodiments are illustrated. First, an endoscopic view(upper right hand corner) from a flexible scope is overlaid on thelaparoscopic view 1090 from a rigid scope (base image). Second, agraphical or virtual representation 1095 of the flexible scope (incontour) is also overlaid on the laparoscopic view 1090 from the rigidscope. By providing such view-in-view capabilities, this helps aphysician to perform multiple procedures concomitantly, and minimizesthe need for unnecessary personnel to perform the individual procedures.

FIG. 37 is a flowchart illustrating an example method operable by arobotic system, or component(s) thereof, for toggling between displayedimages while performing concomitant medical procedures in accordancewith aspects of this disclosure. For example, the steps of method 1100illustrated in FIG. 37 may be performed by processor(s) and/or othercomponent(s) of a medical robotic system (e.g., robotically-enabledsystem 10, or one of the robotic medical systems 200, 300, or 400) orassociated system(s). For convenience, the method 1100 is described asperformed by the “system” in connection with the description of themethod 1100.

The method 1100 begins at block 1101. At block 1105, the system maydeliver a first scope through a first opening of a patient via a firstrobotic arm to obtain a first image. At block 1110, the system maydeliver a second scope through a second opening of the patient via asecond robotic arm to obtain a second image. At block 1115, the systemmay toggle between the first image and the second image on a display. Insome embodiments, the system may further be configured to toggle to aview in which the first image is overlaid on the second image on thedisplay. In other embodiments, the system may be configured to togglebetween toggling between the first image, the second image, and a thirdimage obtained from a pre-operative scan of the patient (e.g., acomputed tomography (CT) scan or a fluoroscopic scan). The system mayfurther be configured to overlay a virtual image over either the firstimage or the second image on the display, as shown in FIG. 36. Themethod 1100 ends at block 1120.

3. Exemplary Methods and Workflows for Concomitant Procedures

There are a number of exemplary methods and workflows which are enabledby the robotic medical systems described herein. One particular examplemedical procedure that can be performed using the described roboticmedical system is colorectal intervention. In colorectal interventionprocedures, physicians may attempt to perform minimally-invasiveinterventions to address colorectal disease, which can be a very complexprocedure. In some cases, treatment of the colorectal disease mayinvolve the removal of colon polyps. While aspects of this disclosuremay use colorectal intervention as a specific example, the systems andmethods described herein can also be used in other procedures as well,such as gastrointestinal and thoracic interventions.

CELS can be utilized for procedures such as, e.g., colorectalintervention and gastrointestinal intervention. For example, certaincolon polyps (such as large sessile polyps or those in difficultlocations relative to the lumen of the colon), cannot be resected with apurely endoscopic approach using current approaches. These polyps can beresected endoscopically, with the assistance of laparoscopicinstrumentation. In these cases, the colon can be repositioned usinglaparoscopic instrumentation to enable endoscopic resection of thepolyp. In addition or as an alternative procedure, endoscopic tools canbe used for localization of a polyp to enable targeted and/or tissuesparing laparoscopic resection of the polyp.

Because laparoscopic assisted endoscopic resection and endoscopicassisted laparoscopic resection may each be less invasive (e.g., theymay have shorter patient recovery times) than purely laparoscopicresection, the use of endoscopic and combined endoscopic/laparoscopicprocedures may potentially lead to better outcomes to patients withpolyps using CELS.

However, there may be a number of challenges to implementing CELS inpractice. One challenge is that CELS can often require a number ofresources and multiple personnel, such as at least four physicians: (i)to control the laparoscopic camera, (ii) to control the laparoscopicinstruments, (iii) to control the endoscopic camera, and (iv) to controlthe endoscopic instruments. In addition to the four physicians, CELS mayalso require a number of clinicians and assistants to support a case.Accordingly, CELS has not been widely adopted and is limited to specificfacilities (e.g., high-end academic centers) that can support multipleclinical providers for a single procedure.

FIGS. 38A and 38B include a flowchart illustrating an example workflowfor performing CELS in accordance with aspects of this disclosure. Forexample, the steps of workflow 1200 illustrated in FIGS. 38A and 38B maybe performed by one or more physicians, clinicians, and/or assistants.For convenience, the CELS workflow 1200 is described as performed by thefour physicians in connection with the description of the workflow 1200.

With reference to FIG. 38A, the workflow 1200 begins at block 1201. Atblock 1205, the workflow 1200 involves one or more physiciansintroducing an endoscope (e.g., a colonoscope) and one or more otherendoscopic instruments into the patient's colon. At block 1210, theworkflow 1200 involves one or more physicians identifying andcharacterizing a target anatomy using the endoscope and the one or moreother endoscopic instruments. At block 1215, the workflow 1200 involvesone or more physicians placing a plurality of laparoscopic ports on thepatient and introducing a laparoscope and one or more laparoscopicinstruments into the patient. These physicians help to establish asterile boundary between a sterile field (e.g., the laparoscopic ports)and the unsterile area (e.g., endoscopic access point, e.g., patient'sanus). The laparoscope and the one or more laparoscopic instrument maybe inserted into the patient's abdominal cavity.

With reference to FIG. 38B, at block 1220, the workflow 1200 involvesinterchangeably using the endoscopic and laparoscopic cameras andinstruments to position the target anatomy for intervention. Thephysicians can view different screens for endoscopic and laparoscopicviews. In other embodiments, the same screen can view both endoscopicand laparoscopic views. At block 1225, the workflow 1200 involvesoptionally exchanging the one or more of the endoscopic and laparoscopicinstruments. At block 1230, the workflow 1200 involves using one or moreof the endoscopic and laparoscopic instruments to perform interventionat the target anatomy. At block 1235, the workflow 1200 involvesremoving all of the endoscopic and laparoscopic cameras and instrumentsand closing the laparoscopic ports. The workflow ends at block 1240.

Aspects of this disclosure relate to a concomitant system that iscapable of performing a CELS. The system is capable of performing bothan endoscopic procedure (e.g., a procedure involving the use of one ormore flexible instruments) and a laparoscopic procedure (e.g., aprocedure involving the use of one or more rigid instruments). Theendoscopic and laparoscopic capabilities are advantageously integratedinto the concomitant system in relatively compact form factor. Inaddition to the compact form factor, the system can be controlled by asingle control unit, thereby advantageously reducing the reliance on alarge number of physicians and assistants in the operating room. Byreducing the reliance on a high number of physicians and assistants whenperforming a CELS, this enables the system to be used prevalently in agreat number of operating and emergency rooms in hospitals worldwidewithout at least some of the above describe drawbacks of the traditionalCELS.

FIG. 39 illustrates an embodiment of a bed-based robotic systemconfigured for performing a concomitant procedure in accordance withaspects of this disclosure. For example, the system 1300 can be used ina method for performing a CELS procedure. The system may be similar tothe system described in connection with FIG. 21.

As shown in FIG. 39, the system 1300 comprises a patient platform 1305comprising a bed 1307 with multiple robotic arms 1310 and 1315 attachedto adjustable arm supports 1311 and 1316. The system 1300 furthercomprises a display 1321, which can be configured to display a livevideo stream. In the present embodiment, the display 1321 comprises atelevision screen. In other embodiments, the display 1321 can be ascreen that is part of a tower monitor, and the video stream can furtherbe piped out to external room monitors via HDMI, SDI, or similar means.

A first set of one or more of the robotic arms 1310 are configured tomanipulate one or more flexible instruments. In some embodiments, theflexible instruments comprise a flexible scope, such as an endoscope,and one or more endoscopic instruments. In the embodiment of FIG. 39,the first set of robotic arms 1310 includes two arms; however, in otherembodiments more or fewer robotic arms 1310 can be used to control theendoscope and/or endoscopic instruments. A second set of one or more ofthe robotic arms 1315 are configured to manipulate one or more rigidinstruments. In some embodiments, the rigid instruments comprise a rigidscope, such as a laparoscope, and one or more laparoscopic instruments.In the embodiment of FIG. 39, the second set of robotic arms 1315includes three arms; however, in other embodiments more or fewer roboticarms 1315 can be used to control the laparoscope and/or laparoscopicinstruments.

The display 1321 can include a large video screen configure to displayfeedback from the flexible scope and/or the rigid scope. In someembodiments, the feedback can include a live video stream from thelaparoscope and/or the endoscope. In other embodiments, the feedback caninclude a virtual representation of the location of the laparoscopic andendoscopic instrument with respect to a model of the patient's anatomy.In the embodiment of FIG. 39, the system 1300 is configured to displayboth live streams from the laparoscope and the endoscope simultaneously.For example, the feedback from the flexible scope and the feedback fromthe rigid scope can be displayed in a picture-in-picture view on thevideo screen. In another example, the feedback from the flexible scopeand the feedback from the rigid scope can be displayed in a side-by-sideview on the video screen.

Although FIG. 39 illustrates an embodiment in which each of the roboticarms 1310 and 1315 is attached to the platform 1305, in alternativeembodiments, the system 1300 can comprise one or more carts, eachcomprising one or more robotic arms. The carts can be in communicationwith each other such that a physician can control the flexibleinstrument(s) and the rigid instrument(s) from a central location. Inone embodiment, the robotic arms 1310 configured to manipulate theflexible instrument(s) can be attached to a first cart while the roboticarms 1315 configured to manipulate the rigid instrument(s) can beattached to a second cart. Examples of systems including cart basedrobotic arms are illustrated in, but not limited to, FIGS. 1, 3, 4, and23.

FIG. 40 is a flowchart illustrating another example workflow forperforming CELS in accordance with aspects of this disclosure. Forexample, the steps of workflow 1400 illustrated in FIG. 40 may beperformed by one or more physicians, clinicians, and/or assistants. Someof the steps of the method 1400 of FIG. 40 may be performed byprocessor(s) and/or other component(s) of a medical robotic system(e.g., robotically-enabled system 10, or one of the robotic medicalsystems 200, 300, 400, 1300, or 1500 discussed above) or associatedsystem(s). Certain steps of the method 1400 may also be performed by thesystem in response to command received from, for example the physician,via an input device (e.g., as shown in FIGS. 29-32) or may be performedautomatically by the system without intervention from a user.

With reference to FIG. 40, the workflow 1400 begins at block 1401. Atblock 1405, the workflow 1400 involves manipulating a flexibleinstrument using a first robotic arm of a robotic system. For example, aphysician may input a first command to the concomitant system 1300 ofFIG. 39 to manipulate the flexible instrument. In some embodiments, thephysician may manipulate the flexible instrument using the first roboticarm through a natural orifice of a patient. At block 1410, the workflow1400 involves manipulating a rigid instrument using a second robotic armof the robotic system. The physician may input a second command to theconcomitant system to manipulate the rigid instrument. In someembodiments, the physician may manipulate the rigid instrument using thesecond robotic arm through an incision formed in the patient. Thephysician may be able to switch between control of the flexibleinstrument and the rigid instrument. In other embodiments, the physicianmay use separate input devices for control of the flexible instrumentand the rigid instrument. Example input devices and interfaces which canbe used by the physician are illustrated in FIGS. 29-32.

At block 1415, the workflow 1400 involves displaying feedback from theflexible instrument. The feedback from the flexible instrument may bedisplayed, for example, by the display 1321 of FIG. 39. At block 1420,the workflow 1400 involves displaying feedback from the rigidinstrument. As is described in detail below, the feedback from theflexible instrument and the feedback from the rigid instrument can bedisplayed in a picture-in-picture view, in a side-by-side view, and/orthe feedback from only one of the flexible and rigid instruments may bedisplayed at a time. The physician may be able to control how thefeedback is displayed. The physician may also be able to select thefeedback from one of the flexible and rigid instruments as a primaryview and the other feedback as a secondary view. The system may displaythe primary and secondary views on the same viewing screen of thedisplay. The method 1400 ends at block 1425.

FIG. 41 illustrates another embodiment of a robotic system configuredfor performing a concomitant procedure in accordance with aspects ofthis disclosure. In particular, the system 1500 of FIG. 41 may beconfigured to perform colorectal intervention using a CELS procedure.

The system 1500 includes robotic arms 1510 and 1515 positioned on a pairof adjustable arm supports 1411 and 1416, thereby allowing the roboticarms 1510 and 1515 to engage a patient 1503 bilaterally. The adjustablearm supports 1411 and 1416 may be coupled to a platform 1507 or bed. Afirst pair of the robotic arms 1510 are used to control one or moreflexible instruments, e.g., one or more endoscopes and/or endoscopictools. In the present embodiment, one of the first pair of robotic arms1510 controls an endoscope 1525 having one or more working channels,while the other of the first pair of robotic arms 1510 controls anendoscopic tool 1530 through the endoscope 1525.

The endoscopic tool 1530 can include, but is not limited to, one or morepolyp removers or receivers including snares (e.g., polyp snares),forceps, nets, graspers, baskets, balloons; injectors (e.g., of dye,markers, or therapeutics); ablation probes; and wires, all of which mayor may not be capable of delivering interventional energy, such aselectrosurgical energy. In addition, the endoscopic tool 1530 canencompass imaging modalities, such as ultrasound or fluorescenceimaging. In some embodiments, the endoscope 1525 and/or endoscopic tool1530 can be used to view and assist in the removal of one or morepolyps, e.g., via one or more cameras installed at a distal end of theendoscope 1525 and/or endoscopic tool 1530. In other embodiments, theendoscope 1525 and/or endoscopic tool 1530 can be used for localizationto enable targeted and/or tissue sparing laparoscopic resection.

In the embodiment illustrated in FIG. 41, a second set of four roboticarms 1515 are used to control one or more rigid instruments, e.g., oneor more laparoscopes and/or laparoscopic tools. For example, one of thesecond set of robotic arms 1515 controls a laparoscope 1535 for viewingthe patient's 1503 abdomen, while the other three robotic arms 1515 ofthe second set control laparoscopic tools 1540, each of which isdelivered through a laparoscopic port (not illustrated) placed on thepatient 1503. The laparoscopic tools 1540 can include but are notlimited to one or more various graspers, retractors, and/or other toolsfor gross manipulation of tissue; dissecting and cutting tools, e.g.paddle forceps, Maryland forceps, scissors, hooks, etc., which may ormay not be capable of delivering electrosurgical energy; and ligatingand suturing tools, such as staplers, vessel sealers, needle drivers,and auto-suture devices. In some embodiments, the laparoscope 1535and/or laparoscopic tools 1540 can be used to view and assist in theremoval of one or more polyps. In other embodiments, the laparoscope1535 and/or laparoscopic tools 1540 can be used to reposition the colon,to better enable endoscopic resection.

In certain embodiments, the robotic arms 1510 and 1515 are placed in astored position when not in use. For example, a CELS procedure may beginwith the use of a flexible instrument controlled by the first roboticarms 1510 during an initial phase or a procedure. In some embodiments,the system may introduce the flexible instrument into a patient via anatural orifice of the patient. The system can manipulate the flexibleinstrument using a first robotic arm of a robotic system through thenatural orifice.

In the case that a purely endoscopic resection is not successful infully treating a condition (e.g., a colon polyp), the system may receivean input signal via a user input device to deploy the second roboticarms 1515. In response to receiving the input signal, the system maydeploy the second robotic arm(s) 1515 of the robotic system from thestored position to a set-up position. The deployment of additionalrobotic arms may be performed as a part of procedure escalation (e.g.,described in the “2. B. Procedure Escalation” section).

The system may then manipulate the rigid instrument using the secondrobotic arms 1515 of the robotic system through an incision formed inthe patient. The system can also display feedback from at least one ofthe flexible instrument and the rigid instrument during the CELSprocedure.

FIG. 42 is an exemplary still image taken from a video screen of theconcomitant system during a simulated colorectal intervention inaccordance with aspects of this disclosure. The still image 1600includes a live feed 1605 from a laparoscope as well as a live feed 1610from an endoscope, formatted in a picture-in-picture view. The live feed1605 from the laparoscope shows a view of the colon 1615 from thepatient's abdomen, as well as a pair of laparoscopic end effectors 1620,respectively attached to laparoscopic tools. The live feed 1610 from theendoscope shows an internal view of the colon.

Advantageously, an operator (e.g., the physician, an assistant, etc.)can switch the views displayed on the video screen and/or the formats inwhich the views are displayed. In other embodiments, rather thanproviding two different live feeds 1605 and 1610 on a video screen, theuser can provide an instruction to freeze one of the one of the livefeeds 1605 and 1610 to become a still image, while the other live feed1605 and 1610 can remain live. In other embodiments, rather thanproviding two different live feeds 1605 and 1610, the user can selectone of the display images to present a virtual view (e.g., a virtualrepresentation of a target anatomy, which can be generated based onpreoperative imaging of the target anatomy), while the other image canbe one of the live feeds 1605 and 1610. In some embodiments, the virtualview can comprise a view of the endoscopic camera and/or instruments orlaparoscopic camera and/or instruments that is based on measured jointand encoder positions of robotic arms and manipulators. In theembodiment of FIG. 42, the live feed 1605 from the laparoscope isdisplayed prominently and can be considered a “primary” feed, while thelive feed 1610 from the endoscope is displayed in a corner region andcan be considered “secondary.” The user may be able to switch theprimary and secondary views such that the live feed 1610 from theendoscope comprises the primary view and the live feed 1605 from thelaparoscope comprises the secondary view.

The concomitant system described herein can be used to provide a numberof improved methods and workflows for concomitant CELS. The sectionsthat follow describe some of the advantages and improvements which canbe achieved using workflows enabled by the concomitant system. Theworkflows described herein can be performed in series and/orsimultaneously, depending on the specific CELS procedure being performed(e.g., based on the type of procedure, the patient, etc.).

A. Patient Preparation

Before performing a CELS procedure using the concomitant system(s)disclosed herein, the physician, clinician(s), and/or assistant(s) mayperform a number of preoperative preparation procedures. One suchprocedure may involve patient preparation.

Patient preparation can include any steps related to preparing a patientprior to performing a surgery (e.g., before an incision is formed). Thiscan include, for example, the clinician(s), assistant(s), and/orphysician(s) identifying sterile and unsterile sites of the patient. Forexample, in preparation for a colonic intervention, a physician canidentify a sterile site (e.g., a region of the patient's abdomen wherelaparoscopic ports are placed) and an unsterile site (e.g., an anus),and can apply a sterile drape to form a sterile boundary between thesterile site and the unsterile site.

Methods for performing patient preparation can be vastly improved usingthe concomitant system(s) described herein. FIG. 43 is a flowchartillustrating an example patient preparation procedure for performingCELS in accordance with aspects of this disclosure. For example, thesteps of method 1700 illustrated in FIG. 43 may be performed by one ormore physicians, clinicians, and/or assistants. Some of the steps of themethod 1700 of FIG. 43 may be performed by processor(s) and/or othercomponent(s) of a medical robotic system (e.g., robotically-enabledsystem 10, or one of the robotic medical systems 200, 300, 400, 1300, or1500 discussed above) or associated system(s). Certain steps of themethod 1700 may also be performed by the system in response to commandreceived from, for example the physician, via an input device (e.g., asshown in FIGS. 29-32) or may be performed automatically by the systemwithout intervention from a user.

With reference to FIG. 43, the method 1700 begins at block 1701. Atblock 1705, the method 1700 involves establishing a sterile boundary. Insome embodiments, a processor of the system can be used to demarcate andidentify the sterile boundary. At block 1710, the method 1700 involvesthe processor identifying a zone of sterility and a zone ofnon-sterility. In some embodiments, the processor may also identify atransition zone between the zone of sterility and the zone ofnon-sterility. In some embodiments, the different zones can beidentified via visual demarcation.

At block 1715, the method 1700 involves the processor maintaining afirst robotic arm within the zone of sterility and a second robotic armwithin the zone of non-sterility. Thus, the processor may prevent arobotic arm or an instrument from crossing over into an undesired zone(e.g., from the zone of sterility to the zone of non-sterility, or viceversa). In some embodiments, the processor can identify the first robotarm as a “sterile” robot arm that can remain in the zone of sterilityand the second robot arm as an “unsterile” robot arm that can remain inthe zone of non-sterility, thereby preventing these robot arms fromcrossing over into undesired areas. In some embodiments, the processormay prevent the first robotic arm and the second robotic arm from movinginto the transition zone, thereby leaving a buffer between the zones. Insome embodiments, the processor may make the user aware via visual orauditory cues that a robotic arm is moving into a transition zone orunsterile zone. In some embodiments, the processor may prompt the userfor confirmation in order to continue moving into the transition zone orunsterile zone. The method 1700 ends at block 1720.

B. Insufflation

During a CELS procedure, it may be desirable to perform insufflation ofone or more regions of a patient's body. For example, the abdomen can beinsufflated or distended (e.g., via a tube that pumps air through one ormore cannulas/ports placed in the abdomen). In addition, the colon canbe insufflated or distended (e.g., via a tube that pumps air through aworking channel of an endoscope). In a colonic intervention procedure,it can be challenging to maintain a proper balance between twoinsufflated regions. For example, insufflation of the abdomen can causeorgans (e.g., such as the colon) to compress, thereby making itdifficult to visualize the colon. Insufflation of two different regions(here the abdomen and the colon) can often compete with one another.

FIG. 44 is a flowchart illustrating an example insufflation procedurefor performing CELS in accordance with aspects of this disclosure. Forexample, the steps of method 1800 illustrated in FIG. 44 may beperformed by one or more physicians, clinicians, and/or assistants. Someof the steps of the method 1800 of FIG. 44 may be performed byprocessor(s) and/or other component(s) of a medical robotic system(e.g., robotically-enabled system 10, or one of the robotic medicalsystems 200, 300, 400, 1300, or 1500 discussed above) or associatedsystem(s). Certain steps of the method 1800 may also be performed by thesystem in response to command received from, for example the physician,via an input device (e.g., as shown in FIGS. 29-32) or may be performedautomatically by the system without intervention from a user.

With reference to FIG. 44, the method 1800 begins at block 1801. Atblock 1805, the processor manipulates a flexible instrument through afirst region of a patient and a rigid instrument through a second regionof the patient. In some embodiments, the flexible instrument ismanipulated through a first orifice (e.g., a natural orifice, such asthe patient's anus) and the rigid instrument is manipulated through asecond orifice (e.g., a man-made incision, which may be formed in theabdomen of the patient).

At block 1810, the processor may insufflate the patient in at least oneof the first region of the patient and the second region of the patient.In some embodiments, the processor may insufflate both the first regionof the patient and the second region of the patient.

At block 1815, the processor may optionally adjusting the insufflationof the second region based on a measurement of the insufflation of thefirst region, or vice versa. For example, the processor can determinewhen sufficient insufflation has been achieved in two different regions,thereby creating a proper balance of insufflation between the region. Insome embodiments, one or more of the tubes configured to pump air intothe patient may also include a pressure sensor configured to take ameasurement of the current insufflation within the corresponding regionof the patient. Thus, the processor may be able to determine theinsufflation in each of the first and second regions based on themeasurements from the pressure sensor(s). In addition, as the system caninclude a video with a live feed, a physician can command the CELSsystem to increase the amount of distention in any of multiple regionsin real time. The method 1800 ends at block 1820.

With the improved CELS system described above, it is advantageouslypossible to integrate insufflation mechanisms and techniques into theproposed system, thereby making it easier to provide distentionmanagement of the overall patient. As opposed to traditional CELSprocedures in which a first clinician may have to manage distention ofone region (e.g., an abdomen) and another may have to manage distentionof another region (e.g., a colon), using the described insufflationprocedure, the CELS system can enable dynamic user control over theamount of insufflation in multiple patient regions (e.g., in both theabdomen and/or the colon), thereby improving endoscopic and laparoscopicvisualization.

C. Imaging

As previously described, feedback from one or more of a flexibleinstrument and a rigid instrument may be displayed on a video screenduring a CELS procedure. In some cases, the internal images of differentanatomical regions and target areas (e.g., cancerous sites) may bedifficult to distinguish from other portions of the patient's anatomydisplayed on the video screen. The viewing of these anatomical regionsand target areas can be assisted by the introduction of visual orfluorescence markers. For example, visual or fluorescent markers (suchas indigo carmine solution, methylene blue, indocyanine green, or othercompounds) can be injected into a patient to better identify andcharacterize legions.

FIG. 45 is a flowchart illustrating an example imaging procedure forperforming CELS in accordance with aspects of this disclosure. Forexample, the steps of method 1900 illustrated in FIG. 45 may beperformed by one or more physicians, clinicians, and/or assistants. Someof the steps of the method 1900 of FIG. 45 may be performed byprocessor(s) and/or other component(s) of a medical robotic system(e.g., robotically-enabled system 10, or one of the robotic medicalsystems 200, 300, 400, 1300, or 1500 discussed above) or associatedsystem(s). Certain steps of the method 1900 may also be performed by thesystem in response to command received from, for example the physician,via an input device (e.g., as shown in FIGS. 29-32) or may be performedautomatically by the system without intervention from a user.

With reference to FIG. 45, the method 1900 begins at block 1901. Atblock 1905, the processor may introduce a marker into a target region ofthe patient using one of the flexible instrument and the rigidinstrument. In some embodiments, the marker is delivered to the patientintravenously. Examples of the marker include visual or fluorescentmarkers (such as indigo carmine solution, methylene blue, indocyaninegreen, or other compounds). At block 1910, the processor may displayfeedback including the target region from one of the flexible instrumentand the rigid instrument on a video screen. Thus, the physician may beable to view the target region via the image displayed on the videoscreen. The method 1900 ends at block 1915.

The improved CELS system provided above can provide a number ofbenefits, such as the ability to communicate and transfer informationbetween different treatment modalities (e.g., endoscopic andlaparoscopic modalities). For example, in one embodiment, an endoscopecan be used to visualize a fluorescently dyed area that may havetraditionally only been viewed by a laparoscope, and vice versa, bydisplaying a live video stream from one or more of the endoscope andlaparoscope. In another embodiment, fluorescent dye can be deliveredintravenously such that both an endoscope and laparoscope can view thesame dyed area. Accordingly, the improved CELS system makes it easier toview fluorescently dyed or marked areas using both an endoscope and alaparoscope. In addition to the use of fluorescence imaging, the systemmay employ narrow band imaging, which can also benefit from having anintegrated endoscope and/or laparoscope to identify and characterize alesion.

D. Navigation

Navigation using the concomitant systems described herein may involvethe driving of one or more scopes and/or instruments through a patient'sanatomy. The flexible endoscope and its associated endoscopicinstrumentation can be driven in novel ways using the concomitant systemdescribed herein. In some embodiments, the flexible instrument isconfigured to be driven through an outer sheath, for example, of aflexible colonoscope. The flexible instrument can include one or moreworking channels configured to facilitate delivery a surgical instrumenttherethrough. For example, in a colorectal intervention, the flexiblecolonoscope can be viewed as a “mother” instrument and anyinstrumentation therein through the working channel of the colonoscopecan be viewed as a dependent “daughter” instrument, such the mother anddaughter instruments can be navigated together.

In another embodiment, an outer sheath can be viewed as a “mother” andthe colonoscope and any instrumentation therethrough can be viewed asdependent “daughters” that travel through the outer sheath. In otherwords, the improved CELS system allows navigation of elongated members(e.g., outer sheath, scope and working instruments) to be performed.

E. Integration of Flexible and Rigid Instrumentation

The improved CELS systems described herein uniquely integrates bothflexible and rigid instrumentation. The system allows for the navigationand control of both types of instruments, thereby allowing for novelprocedures, including those involving procedure escalation, as describedherein.

In one example of a procedure involving control of both flexible andrigid instrumentation, a flexible instrument (e.g., such an outersheath, an inner sheath, and a working instrument) can be driven by arobotic arm in an initial attempt to perform a resection of targetanatomy. Following the initial attempt, laparoscopic ports andinstruments may be provided if desired to perform the resection ifdesired. In some embodiments, the laparoscopic ports can be betweenabout 3-14 mm (e.g., to accommodate 12 mm laparoscopes, 8 mminstruments, and instruments as small as 3 mm). In some embodiments, alarger hand or gel port can be used in place of or in addition tostandard laparoscopic ports. When both endoscopic and laparoscopicscopes and tools are used, the improved CELS system described herein canswitch control between each of the endoscopic and laparoscopic scopesand tools, thereby allowing a user to control both using, for example,one or more controllers.

Advantageously, in some embodiments, the same controller (e.g., one ormore handles 815 illustrated in FIG. 31 or a single input device such asthe pendant 820 illustrated in FIG. 32) can be used to control both theendoscopic and laparoscopic scopes and tools. The single input devicecan be any type of controller, including a multi-DOF (e.g., 7-DOF)master controller (e.g., see the master controller 810 illustrated inFIG. 30) with a gimbal or a gamepad type device (e.g., a pendant 820).The single input device can be used to switch between control of anendoscope, flexible endoscopic instruments, laparoscope, and rigidlaparoscopic instruments.

In other embodiments, multiple controllers can be used to control boththe endoscopic and laparoscopic scopes and tools. An advantage of havingmultiple controllers is that it is possible to have multiple users(e.g., a pair of physicians) control different aspects of the CELSsystem concurrently if desired. In addition, another advantage of havingmultiple controllers is that they can be positioned be at differentlocations—for example, one controller can be at a surgeon console, whileanother controller is at a bedside. In one embodiment, a set of userscould synchronously control rigid and flexible instruments, whereby onecan control rigid instruments from a multi-DOF (e.g., 7-DOF) master at asurgeon console, and the other can control flexible instruments from apendant at a bedside. In another embodiment, a set of users cansynchronously control rigid and flexible instruments, whereby one cancontrol rigid instruments using one type of controller, and the othercan control flexible instruments using the same type of controller.

However, in other embodiments, a single user may input commands forcontrolling rigid and flexible instruments via the pendant and themaster controller. For example, the single user may input commands forcontrolling rigid instruments using one type of controller and inputcommands for controlling flexible instruments using another type ofcontroller. This may enable the user to switch between control of anendoscopic instrument and a laparoscopic instrument by inputting thecommands into separate devices, rather than changing an input mode ofthe system.

F. UI/UX

In traditional CELS procedures, one or more surgeons may view an imagefrom an endoscope on a first screen and a view an image from alaparoscope on a second, separate screen. The surgeons will often turntheir heads back and forth to analyze the different views from theendoscope and laparoscope.

The improved CELS systems described herein can enable the establishmentof live video streams from one or both of the laparoscope and endoscope(e.g., colonoscope) through a single video pipeline. To enable this, thesystem may include two independent video processors that pipe videoreceived from the endoscope and laparoscope into an image outputpathway. The image output pathway can be output on a tower monitorand/or to operating room monitors. Using a single CELS system to controlboth video streams enables a user to determine whether a given monitorshould display a laparoscopic view, an endoscopic view, or both (e.g.,picture-in-picture or side-by-side). Thus, the system can be configuredto display feedback from the laparoscope and the endoscope in apicture-in-picture view and/or a side-by-side view.

The improved CELS system can be configured to switch between thelaparoscopic view and endoscopic view on any connected display unit,whereby a display unit can be any of a tower monitor, operating roommonitor, physician console display, or alternative third-person bedsidevisualization unit. In some embodiments, the processor may identify oneof the feedback from the endoscope and the feedback from the laparoscopeas a primary view and the other as a secondary view. The processor canthen switch the primary and secondary views based on input received froma user.

Switching of views on any of the connected display units can include:(i) switching between full-screen laparoscopic view and endoscopic viewon a single monitor; (ii) switching between full-screen laparoscopic orendoscopic view and picture-in-picture or side-by-side (or anycombination of these); and (iii) switching which monitors are displayingwhich content (e.g., switching monitor A from laparoscopic to endoscopicview and monitor B from endoscopic to laparoscopic view, or vice versa).Thus, the system may enable any combination of views to be displayed oneach display unit independently.

G. Exemplary Advantages and Improvements

The systems described above, which use robotic arms to controlendoscopic instrumentation, laparoscopic instrumentation, or both,affords several benefits. One benefit includes enabling robotic controlof one or both tool types (flexible/endoscopic and rigid/laparoscopic)which reduces the need to have a high number of physicians and personnelfor performing particular procedures. For example, rather than havingthree of four physicians remaining still while the fourth manipulatesthe instrument, robotic arms can hold the static instruments still. Insuch a case, a flexible instrument can be manipulated to polyp snare thepolyp while the laparoscopic instruments, while the laparoscopicinstruments, laparoscope, and colonoscope remain still.

In addition, the system can control of instrumentation with robotic armswhich allows kinematic and sensor-based determination of the location ofthe instrument shafts and tips. This information can allow a user to seegraphics-based renderings of the location and position of robotic armsand instrumentation at all times. This may include 3-D volume renderingsof a robot and instrumentation, 2-D line drawings of robot andinstrumentation, or visual overlays of flexible instrumentation fromwithin the rigid laparoscope (or vice versa, as shown in FIG. 36).

4. Implementing Systems and Terminology

Implementations disclosed herein provide systems, methods and apparatusfor performing concomitant medical procedures.

It should be noted that the terms “couple,” “coupling,” “coupled” orother variations of the word couple as used herein may indicate eitheran indirect connection or a direct connection. For example, if a firstcomponent is “coupled” to a second component, the first component may beeither indirectly connected to the second component via anothercomponent or directly connected to the second component.

The functions associated with the systems, methods, and workflows forperforming concomitant procedures described herein may be stored as oneor more instructions on a processor-readable or computer-readablemedium. The term “computer-readable medium” refers to any availablemedium that can be accessed by a computer or processor. By way ofexample, and not limitation, such a medium may comprise random accessmemory (RAM), read-only memory (ROM), electrically erasable programmableread-only memory (EEPROM), flash memory, compact disc read-only memory(CD-ROM) or other optical disk storage, magnetic disk storage or othermagnetic storage devices, or any other medium that can be used to storedesired program code in the form of instructions or data structures andthat can be accessed by a computer. It should be noted that acomputer-readable medium may be tangible and non-transitory. As usedherein, the term “code” may refer to software, instructions, code ordata that is/are executable by a computing device or processor.

The methods disclosed herein comprise one or more steps or actions forachieving the described method. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isrequired for proper operation of the method that is being described, theorder and/or use of specific steps and/or actions may be modifiedwithout departing from the scope of the claims.

As used herein, the term “plurality” denotes two or more. For example, aplurality of components indicates two or more components. The term“determining” encompasses a wide variety of actions and, therefore,“determining” can include calculating, computing, processing, deriving,investigating, looking up (e.g., looking up in a table, a database oranother data structure), ascertaining and the like. Also, “determining”can include receiving (e.g., receiving information), accessing (e.g.,accessing data in a memory) and the like. Also, “determining” caninclude resolving, selecting, choosing, establishing and the like.

The phrase “based on” does not mean “based only on,” unless expresslyspecified otherwise. In other words, the phrase “based on” describesboth “based only on” and “based at least on.”

The previous description of the disclosed implementations is provided toenable any person skilled in the art to make or use the presentinvention. Various modifications to these implementations will bereadily apparent to those skilled in the art, and the generic principlesdefined herein may be applied to other implementations without departingfrom the scope of the invention. For example, it will be appreciatedthat one of ordinary skill in the art will be able to employ a numbercorresponding alternative and equivalent structural details, such asequivalent ways of fastening, mounting, coupling, or engaging toolcomponents, equivalent mechanisms for producing particular actuationmotions, and equivalent mechanisms for delivering electrical energy.Thus, the present invention is not intended to be limited to theimplementations shown herein but is to be accorded the widest scopeconsistent with the principles and novel features disclosed herein.

What is claimed is:
 1. A surgical method, comprising: manipulating aflexible instrument using a first robotic arm of a robotic system;manipulating a rigid instrument using a second robotic arm of therobotic system; displaying feedback from the flexible instrument; anddisplaying feedback from the rigid instrument.
 2. The method of claim 1,wherein: the flexible instrument comprises a flexible scope; the rigidinstrument comprises a rigid scope; and at least one of the feedbackfrom the flexible scope and the feedback from the rigid scope isdisplayed on a video screen.
 3. The method of claim 2, wherein thefeedback from the flexible scope and the feedback from the rigid scopeare displayed in a picture-in-picture view.
 4. The method of claim 2,wherein the feedback from the flexible scope and the feedback from therigid scope are displayed in a side-by-side view.
 5. The method of claim2, wherein one of the feedback from the flexible scope and the rigidscope comprises a primary view and the other of the feedback from theflexible scope and the rigid scope comprises a secondary view.
 6. Themethod of claim 5, further comprising: switching the primary andsecondary views such that the feedback from the flexible scope comprisesthe primary view and the feedback from the rigid scope comprises thesecondary view.
 7. The method of claim 1, further comprising:identifying a zone of sterility and a zone of non-sterility.
 8. Themethod of claim 7, wherein a drape is positioned between the zone ofsterility and the zone of non-sterility.
 9. The method of claim 7,further comprising: maintaining one of the first robotic arm or thesecond robotic arm within the zone of sterility; and maintaining theother of the first robotic arm and the second robotic arm within thezone of non-sterility.
 10. The method of claim 9, further comprising:identifying a transition zone between the zone of sterility and the zoneof non-sterility.
 11. The method of claim 10, further comprising:preventing the first robotic arm and the second robotic arm from movinginto the transition zone.
 12. The method of claim 1, wherein theflexible instrument is manipulated through a first region of a patientand the rigid instrument is manipulated through a second region of thepatient.
 13. The method of claim 12, wherein the flexible instrument ismanipulated through a first orifice and the rigid instrument ismanipulated through a second orifice.
 14. The method of claim 13,wherein the first orifice comprises a natural orifice and the secondorifice comprises a man-made incision.
 15. The method of claim 14,wherein the natural orifice comprises the patient's anus and theman-made incision is formed in an abdomen of the patient.
 16. The methodof claim 12, further comprising: insufflating the patient at one of thefirst region of the patient and the second region of the patient. 17.The method of claim 16, further comprising: insufflating both the firstregion of the patient and the second region of the patient.
 18. Themethod of claim 17, further comprising: adjusting the insufflation ofthe second region based on a measurement of the insufflation of thefirst region.
 19. The method of claim 1, wherein the first robotic armand the second robotic arm are positioned on an adjustable arm support.20. The method of claim 19, wherein the adjustable arm support iscoupled to a bed.
 21. The method of claim 20, wherein the bed comprisesa pair of adjustable arm supports, each of the pair of adjustable armsupports having one or more robotic arms attached thereto.
 22. Themethod of claim 1, wherein the flexible instrument is configured to bedriven through an outer sheath.
 23. The method of claim 22, wherein theflexible instrument comprises one or more working channels configured tofacilitate delivery a surgical instrument therethrough.
 24. The methodof claim 23, wherein the surgical instrument comprises a polyp snare.25. The method of claim 1, further comprising: introducing a marker intoa target region of the patient using one of the flexible instrument andthe rigid instrument.
 26. The method of claim 25, wherein the marker isdelivered to the patient intravenously.
 27. The method of claim 1,wherein: manipulating the flexible instrument using the first roboticarm is performed in response to input received via a pendant, andmanipulating the rigid instrument using the second robotic arm isperformed in response to input received via a master controller.
 28. Themethod of claim 27, wherein the input received via the pendant and theinput received via the master controller are received from a singleuser.
 29. The method of claim 1, wherein: manipulating the flexibleinstrument using the first robotic arm is performed in response to inputreceived via a master controller, and manipulating the rigid instrumentusing the second robotic arm is performed in response to input receivedvia the master controller.
 30. The method of claim 1, furthercomprising: performing a Combined Endoscopic and Laparoscopic Surgery(CELS) procedure using the flexible instrument and the rigid instrument.